Drug Recall Cumberland Pharmaceuticals Acetadote Vials
Drug Recall
FOR IMMEDIATE RELEASE – NASHVILLE, Tenn., Dec. 30, 2010 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has implemented a drug recall of 6 lots of Acetadote® (acetylcysteine) Injection, the Company’s injectable treatment to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. Cumberland informed the U.S. Food and Drug Administration (FDA) of its plans to issue a voluntarily drug recall of these lots of Acetadote as a precautionary measure based on observed particulate matter found in a very small number of vials. The source of the particulate matter was from the glass vial produced by a former supplier. The drug recall, which is not being undertaken on the basis of any known adverse medical events, affects a limited supply of product.
Drug Recall Cumberland Pharmaceuticals Acetadote Vials
“We are recalling certain lots manufactured by a previous packaging supplier as a precautionary measure, and believe the risk of any serious adverse medical events to be remote,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “As part of ongoing quality assessment, we switched to a new vial packaging supplier in August of 2009. Patient safety, as always, remains our highest priority, and we are committed to taking the necessary steps to proactively protect patients from the potential of any safety risks.”
The product being recalled is Acetadote (acetylcysteine) Injection, 20% solution (200mg/mL) in 30 mL single dose glass vials, NDC 66220-107-30. The lot numbers being recalled are lots 090304 (expiration Feb 2011), 090331 (expiration Feb 2011), 090401 (expiration Mar 2011), 090511 (expiration Apr 2011), 090602 (expiration May 2011) and 090616 (expiration May 2011). This product was distributed to U.S. wholesalers and distributors nationwide.
To report adverse reactions or quality concerns, please contact Cumberland Pharmaceuticals via email at aereport@cumberlandpharma.com, by fax to 866-438-2372 or by phone at 1-877-484-2700. Adverse reactions may also be reported to FDA’s MedWatch Program online at www.fda.gov/medwatch, or by mail at MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
About Acetadote
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company’s primary target markets include hospital acute care and gastroenterology. Cumberland’s product portfolio includes Acetadote® for the treatment of acetaminophen poisoning, Caldolor®, the first injectable treatment for pain and fever approved in the United States, and Kristalose®, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information on Cumberland Pharmaceuticals, please visit the Company’s website at www.cumberlandpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland’s current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland’s operations are subject to factors outside its control, and any one or combination of these factors could materially affect Cumberland’s results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland’s products on a timely basis or a failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors set forth under the headings “Risk factors” and “Management’s discussion and analysis of financial condition and results of operations” in Cumberland’s Form 10-K filed with the SEC on March 19, 2010. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.
Drug Recall
Drug Recall Reese Pharmaceutical Co Nationwide Recall
Drug Recall
Contact:
Russ Slaby, Vice President
1-800-321-7178
Drug Recall Reese Pharmaceutical Over The Counter Drug
FOR IMMEDIATE RELEASE – December 9, 2010 – Reese Pharmaceutical Company of Cleveland, Ohio has voluntarily issued a drug recall of lot# 091612 only in 60-count size bottles identified under four different brand names, listed in the table below, because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200mg Guaifenesin tablets. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.
| Product Name | NDC# | Lot# |
| Refenesen Expectorant (guaifenesin 200 mg tablets) | 10956-752-60; | 091612 05/11 SS/SCT36 06/26/09 |
| Select Brand Mucus Relief Expectorant (guaifenesin 200 mg) | 15127-129-60 | 091612 05/11 SS/SCT36 06/26/09 |
| QC Medifin Expectorant (guaifenesin 200 mg) | 63868-754-60 | 091612 05/11 SS/SCT36 06/26/09 |
| Leader Cough Tabs Expectorant (guaifenesin 200 mg) | 37205-466-72 | 091612 05/11 SS/SCT36 06/26/09 |
The mislabeled product does not warn consumers that Acetaminophen may cause liver damage. Ingesting high doses of Acetaminophen can potentially cause severe liver damage. The likelihood of acute liver damage is higher among consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day. Overdose may specially occur if consumers are also taking other cold/cough products that contain Acetaminophen in addition to the mislabeled product. Contraindications for Phenylephrine are high-blood pressure, poor blood flow to the extremities, and patients on antidepressants known as MAO Inhibitors. Furthermore, products that contain Phenylephrine should be used with caution in patients with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product. However, to date, there have been no reports of adverse events from its use.
This product was distributed nationwide. Consumers who have purchased the product ( lot # 091612 only) should contact Russ or Neal Slaby at 1.800.321.7178 between 7:30-4:00pm eastern standard time for return instructions, medical information, questions, complaints or assistance.
This drug recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Notification of the recall has been sent to all customers who purchased this product directly from Reese Pharmaceutical Company.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online:http://www.fda.gov/MedWatch/report.htm9
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
Drug Recall
Categories: Drug Recall Tags: FDA Recall, Food And Drug Administration Recall, Shirley Medical Family Healthcare
Drug Recall The Ritedose Corporation Issues Voluntary Recall
Drug Recall
Contact:
The Ritedose Corporation
803-935-3995
recall@ritedose.com
FOR IMMEDIATE RELEASE – December 30, 2010 – The Ritedose Corporation is conducting a voluntary drug recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose vials). This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. This product is part of a drug recall because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products are included in this drug recall.
Drug Recall The Ritedose Corporation Issues Voluntary Recall
The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a shelf carton. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons. This product was distributed nationwide and Puerto Rico.
Administration of this defective product could result in a range of potential health effects that spans from temporary and medically reversible to life threatening and death. There is significant concern that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of product used resulting in an administered amount that is 5 times the recommended dose. In the hospital setting, the vials are often not accompanied by the rest of the packaging, making it more likely that such a dosing error could occur. Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute.
The Ritedose Corporation is working cooperatively with the U.S. FDA to implement a nationwide recall as quickly and efficiently as possible.
Consumers should immediately return the affected product to the place it was obtained (i.e. doctor’s office, pharmacy, etc.). Wholesalers and retailers should return the product to the following address:
Total Product Destruction
Attn: RECALL
8025 Howard Street
Spartanburg, SC 29303
For more information concerning this recall contact The Ritedose Corporation directly at phone: 803-935-3995 Monday through Friday 8am to 5 pm EST or by e-mail: recall@ritedose.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.
- Online:http://www.fda.gov/MedWatch/report.htm9
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10 . Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
Drug Recall
Drug Recall Johnson & Johnson-Merck Mylanta and Alternagel
Drug Recall
Contact:
Consumer Care Center
1-800-469-5268
FOR IMMEDIATE RELEASE – November 29, 2010 – In consultation with the U.S. Food and Drug Administration (FDA), Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. (JJMCP) is issuing a drug recall, from the wholesale and retail level, twelve MYLANTA® liquid products and one AlternaGEL® liquid product. JJMCP is conducting the recall in order to update the labeling for these products. The specific products involved in this drug recall, listed below, are being recalled in the United States and Puerto Rico.
Drug Recall Mylanta and Alternagel
JJMCP initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was not noted on the packaging. Certain flavoring agents contribute small (< 1%) amounts of alcohol. It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity related adverse events.
This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product.
Consumers with questions should call our Consumer Care Center at 1-800-469-5268 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)
The NDC codes and lot numbers for the recalled products can be found in the below list and on the bottle.
| Product | NDC Number | Lot Number | UPC |
| MYLANTA® REGULAR STRENGTH ORIGINAL 12 FL OZ | 16837-162-12 | AAF075, ABF005, ABF033
ABF068, ACF008, ACF054 ADF063, AEF024, AHF004 AHF016, AHF051, AJF026 ALF030, AMF016, AMF046 AMF047, APF064, APF074 ASF041, BAF028, BAF045 BAF049, BBF008, BCF051 BDF026, BDF045, BEF029 BEF043, BFF001, BFF020 BHF029, BHF031, BHF032 BJF017, BJF045, BJF046 BJF047, BLF025, BMF004 BMF023, SSF064, SSF078 |
716837610120 |
| MYLANTA® ORIGINAL 5 FL OZ | 16837-162-55 | AAF071, AAF072, ADF048
ADF049, AFF016, AFF032 AJF038, AJF039, ASF056 BCF038, BDF046, BEF052 BFF003, BMF003, SSF053 |
716837610557 |
| MYLANTA® REGULAR STRENGTH MINT 12 FL OZ | 16837-138-12 | ADF026, BCF037,
BHF028, SSF006 |
716837629122 |
| MYLANTA® MAXIMUM STRENGTH CHERRY 12 FL OZ | 16837-136-12 | AAF022, ABF004, ABF067
ACF016, ADF011, ADF090 AEF051, AFF038, AHF003 AJF010, ALF050, APF028 BAF023, BCF010, BCF071 BCF086, BDF056, BEF054 BFF019, BFF034, BFF035 BFF042, BHF003, BJF005 BJF030, BMF005, BMF024 SPF066, SSF017, SSF051 SSF073 |
716837622123 |
| MYLANTA® MAXIMUM STRENGTH MINT 12 FL OZ | 16837-137-12 | AAF091, ABF081, ACF039
ADF062, AEF030, AFF031 AHF015, ALF027, AMF033 APF063, BAF046, BCF035 BDF030, BEF028, BEF056 BFF018, BHF004, BJF018 BJF040, BJF041, BLF016 SPF067, SSF016 |
716837624127 |
| MYLANTA® MAXIMUM STRENGTH ORIGINAL 12 FL OZ | 16837-163-12 | AAF073, AAF092, ACF007
ACF038, ACF059, ADF050 AEF025, AEF055, AEF060 AHF005, AHF044, AJF007 ALF049, APF076, ASF039 BAF009, BBF003, BCF036 BCF085, BDF034, BDF057 BEF031, BFF016, BHF011 BHF012, BHF027, BHF039 BJF011, BJF031, BLF001 BLF017, BMF018, BMF025 SSF014, SSF062, SSF075 |
716837652120 |
| MYLANTA® MAXIMUM STRENGTH ORIGINAL 24 FL OZ | 16837-163-24 | AAF018, AAF023, ABF034
ABF066, ACF021, ACF027 ADF024, AHF035, AHF037 AJF025, ALF028, AMF039 ASF054, BAF014, BBF029 BCF084, BEF011, BEF023 BFF017, BHF006, BJF037 |
716837652243 |
| MYLANTA® ULTIMATE STRENGTH MINT 12 FL OZ | 16837-643-12 | AJF008, ASF017
BDF017, BDF017A |
716837643128 |
| MYLANTA® ULTIMATE STRENGTH CHERRY 12 FL OZ | 16837-644-12 | ABF078, ADF013, ADF093
AFF015, AHF043, AJF006 AJF006A, ALF004, AMF026 APF031, ASF055, BBF014 BBF014A, BDF001, BDF055 BEF030, BHF024, BJF006 BJF019, BLF002, SPF024 |
716837644125 |
| MYLANTA® SUPREME TASTING WITH CALCIUM CHERRY 12 FL OZ | 16837-825-12 | ACF040, AEF029, AHF045
ALF051, ASF040, BBF015 BEF026, BHF001, BJF032 SPF068 |
716837825128 |
| MYLANTA® SUPREME TASTING WITH CALCIUM CHERRY 24 FL OZ | 16837-825-24 | AAF090, ADF023, AHF042
AMF040, BCF083, BHF038 |
716837825241 |
| MYLANTA® MAXIMUM STRENGTH ORIGINAL 12 FL OZ | 16837-163-12 | 0089N11, 0089N11A, 0089N11B
0369N11, 0369N21, 0559N28 0689N12, 0689N22, 1069N21A 1079N11, 1209N22A, 1219N12 1219N22, 1569N12, 1569N12A 1569N22, 2229N11, 2229N21 3068N12, 3588N21 |
716837652151 |
| ALTERNAGEL® 12 FL OZ | 16837-860-12 | ADF012, ASF057, BLF006 | 716837860129 |
Drug Recall
Categories: Drug Recall Tags: FDA Recall, Food And Drug Administration, Shirley Medical Family Healthcare
Lipitor Recall Pfizer To Recall Lipitor In The U S
Lipitor Recall
Contact:
Pfizer
1-888-LIPITOR
FOR IMMEDIATE RELEASE – December 22, 2010 – Pfizer has announced that it intends a Lipitor recall one lot—approximately 19,000 bottles—of Lipitor 40 mg tablets (atorvastatin calcium) distributed in the U.S. The Lipitor recall stems from one customer report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged. The bottles were supplied by a third-party bottle manufacturer.
Lipitor Recall
A medical assessment found that the risk of health consequences to patients appears to be minimal.
The market action is the result of Pfizer’s increased surveillance of odor-related issues after other reports in the industry. This increased surveillance also led to three earlier recalls of Lipitor, implemented in August, October and November of 2010, in response to infrequent complaints of uncharacteristic odor.
The odor is consistent with the presence of 2, 4, 6 tribromoanisole (TBA), which was found at a very low level in a complaint sample bottle during the investigation leading to the first product recall. Research indicates that a major source of TBA appears to be 2, 4, 6-tribromonophenol (TBP), a chemical used as a wood preservative. Although TBP often is applied to pallets used to transport and store a variety of products, Pfizer prohibits the utilization of TBP-treated wood in the shipment of its medicines.
For the U.S. FDA’s perspective on TBA and health risk, click on the following web site: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm192869.htm#59
The company has taken quick action to ensure its product continues to meet the company’s high quality and patient safety standards. We have identified the source of the odor, and we are enacting rigorous measures to prevent odor-related issues going forward. The lot that will be recalled was packaged and shipped before these changes went into effect in August of this year. As previously reported, product filled in bottles made by the supplier prior to those changes may still be on the market, so it is possible that additional recalls could be necessary.
Pfizer has a very rigorous quality and compliance program that includes a highly sensitive surveillance system, which has enabled Pfizer to quickly detect and respond to the odor-related issue. Our market actions reflect the rigor of our quality control system and a commitment to act rapidly and in the best interest of our customers. The well being of patients who take our medicines is our first priority.
Pfizer does not anticipate a product shortage resulting from the recall.
LIPITOR Recall Information
Pfizer recalled specific bottles of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which LIPITOR is packaged. A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. There is no need to take any action if you take LIPITOR; please continue to take your medication as prescribed by your doctor. However, if you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.
Pfizer is committed to the safety of patients who take our medicines. Pfizer is working closely with the bottle supplier to determine the cause of the odor problem and to rapidly address it. Pfizer responded rapidly to ensure LIPITOR continues to meet the company’s high quality standards. We will continue to actively monitor the situation and take any action necessary to ensure patient safety and maintain the quality of our products.
If you have any questions about LIPITOR, please contact your doctor or your pharmacist or call 1-888-LIPITOR.
Common Questions
Why was LIPITOR recalled?
Pfizer has recalled specific “lots” or batches of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which the product is packaged. We have identified the source of the odor, and we are implementing rigorous measures to prevent odor-related issues going forward.
Where can people go for more information about the recall?
If you have any questions about the recall please call 1-888-LIPITOR. If you have specific questions about your medication, you may also call your doctor or pharmacist.
I take LIPITOR. What should I do?
Pfizer recalled only specific bottles of LIPITOR 40 mg due to a small number of reports of an uncharacteristic odor and a medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. Medication should always be taken as prescribed by a doctor. If you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.
If you take LIPITOR and experience an odd smell or odor, what should you do?
Pfizer recalled only specific bottles of LIPITOR 40 mg due to a small number of reports of an uncharacteristic odor and a medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. If you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist. If you have any concerns, call your doctor or pharmacist or call 1-888-LIPITOR if you need any further information.
Is it still safe to take LIPITOR?
Pfizer has recalled only specific bottles of LIPITOR 40 mg due to a small number of reports of an uncharacteristic odor related to the bottles in which LIPITOR is packaged. A medical assessment has determined the odor is not likely to cause adverse health consequences in patients taking LIPITOR. Pfizer remains confident in the safety and efficacy of LIPITOR.
Will there be a LIPITOR 40 mg shortage as a result of the recall?
Pfizer has taken a number of steps to ensure that there is no shortage of LIPITOR 40 mg as a result of this recall.
Can I have my LIPITOR 40 mg replaced if it has an odd smell or odor?
Pfizer has recalled only specific bottles of LIPITOR 40 mg. Please speak to your pharmacist about replacement policies.
What are the LIPITOR LOT numbers that are recalled?
| Lipitor® 40 mg Tablets (atorvastatin calcium) Recall Informaiton |
|
| Lots | Date of Recall |
| 0836050 | 12/17/10 |
| 0660060 | 11/2/10 |
| 0682060 | 11/2/10 |
| 0628040 | 10/13/10 |
| 0672040 | 10/13/10 |
| 0673040 | 10/13/10 |
| 0754040 | 10/13/10 |
| 0755040 | 10/13/10 |
| 0763040 | 10/13/10 |
| 0764040 | 10/13/10 |
| 0765040 | 10/13/10 |
| 0788040 | 10/13/10 |
| 0540050 | 10/13/10 |
| 0855020 | 8/18/10 |
| 0819020 | 8/18/10 |
| 0842020 | 8/18/10 |
| 0843020 | 8/18/10 |
| 0854020 | 8/18/10 |
LIPITOR (atorvastatin calcium) is a prescription medicine that is used along with a low-fat diet. It lowers the LDL (“bad”) cholesterol and triglycerides in your blood. It can raise your HDL (“good”) cholesterol as well. LIPITOR can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as age, smoking, high blood pressure, low HDL, or family history of early heart disease.
LIPITOR can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure.
IMPORTANT SAFETY INFORMATION
LIPITOR is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.
If you take LIPITOR, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Tell your doctor about all medications you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before and during treatment and may adjust your dose.
Common side effects are diarrhea, upset stomach, muscle and joint pain, and changes in some blood tests.
When diet and exercise alone are not enough, adding LIPITOR can help lower cholesterol. LIPITOR is one of many cholesterol-lowering treatment options that you and your doctor can consider.
Lipitor Recall
Drug Recall McNeil Consumer Healthcare Recalls All Rolaids
Drug Recall
Contact:
McNeil Consumer Healthcare
http://www.rolaids.com9
1-888-222-6036
FOR IMMEDIATE RELEASE – December 9, 2010 – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is issuing a voluntarily Drug Recall of all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews (full product details below) distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.
Drug Recall Rolaids
While our investigation is ongoing we have suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews and will not restart production until corrective actions have been implemented.
Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com10
or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund. Consumers who have medical concerns or questions should contact their healthcare provider.
There have been no adverse reactions as a result of products associated with this Drug Recall. Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: http://www.fda.gov/MedWatch/report.htm11
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm12. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Product Information: Product NDC numbers can be located on the label of the package above the brand name. Lot Numbers and Expiration Dates can be found on back, side or bottom label of the package. If you cannot find the NDC number, lot number, or expiration date on the label, Click here13 for examples or call the Consumer Care Center at 1-888-222-6036.
CLICK HERE14 TO FIND OUT IF YOUR ROLAIDS® SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.
FULL RECALLED PRODUCT LIST:
Product Name Lot Number UPC
ROLAIDS® Extra Strength Softchews, Wild Cherry
ROLAIDS® Extra Strength Softchews, Wild Cherry, 6 count 9015A, 9016A, 9019A, 9140A, 9138A,9210A, 9211A,9315A, 9316A 312547655200
ROLAIDS® Extra Strength Softchews, Wild Cherry, 18 count (3 packs of 6 count) 9075A, 9076A, 9103A, 9098A, 9104A, 9239A, 9240A, 9348A 312547655255
ROLAIDS® Extra Strength Softchews, Wild Cherry, 42 count (7 packs of 6 count) 9065A, 9068A, 9069A, 9131A, 9132A, 9208A, 9209A, 9286A, 9287A 312547655316
ROLAIDS® Extra Strength Softchews, Cherry
ROLAIDS® Extra Strength Softchews, Cherry, 6 count 0109A, 0114A, 0115A, 0134A, 0135A, 0165A, 0238B, 0239A, 0239C, 0262A, 0264A 312547655200
ROLAIDS® Extra Strength Softchews, Cherry, 18 count bag 9349AG2, 9350AG1, 0015AG2, 0015AG3, 0050AG1, 0051AG1, 0053BG2, 0106BG2, 0107AG1, 0108AG1, 0108BG3, 0108CG1, 0129BG1, 0133AG1, 0133AG2, 0165BG2, 0191BG1, 0191CG1, 0191DG1, 0213AG2, 0238AG1, 0238AG2, 0246AG1 300450649188
ROLAIDS® Extra Strength Softchews, Cherry, 36 count bag 9350AG2, 0012AG1, 0013AG1, 0014AG1, 0015AG1, 0015AG4, 0050AG2, 0053AG2, 0053BG1, 0053BG2, 0094AG1, 0106AG1, 0106BG1, 0108AG2, 0108BG2, 0191AG1, 0139BG2, 0165BG1, 0191BG1, 0207AG1, 0207AG2, 0213AG1, 0227AG1, 0246AG2, 0247AG1, 0265AG1, 0266AG1 300450649362
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 6 count 9005A, 9006A 312547065733
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 12 count (2 packs of 6 count) 9022A, 9027A, 9118A, 9119A, 9195A, 9196A 312547065757
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 36 count (6 packs of 6 count) 9166A, 9167A 312547065771
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 6 count 0017B, 0095A, 0096B, 0259A, 0260A 300450657060
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 12 count bag 9351BG1, 9352AG1, 0016AG1, 0059AG2, 0059BG1, 0059BG2, 0060AG2, 0167AG2, 0167AG3, 0203AG1, 0204AG1 300450657121
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 24 count bag 9352AG2, 9352BG2, 0016AG2, 0017AG1, 0057BG1, 0058AG1, 0059AG1, 0059BG3, 0060AG1, 0129AG1, 0132AG1, 0167AG1, 0167BG1, 0204AG2, 0205AG1, 0230AG1, 0231AG1 300450657244