Motrin Recall

From Pharmacy Drug Guide

In December 2011, Johnson and Johnson issued a recall of Motrin IB pain relievers. According to a release by McNeil Consumer Healthcare, consumers do not need to return Motrin because there are no safety concerns. However, as the tablets age, the coating may dissolve more slowly than expected. Consumers with questions or concerns can call McNeil's Consumer Call Center at 1-888-222-6036, Monday-Friday 8 a.m. to 8 p.m. Eastern Time.^{[1] [2]}

This is the sixth recall of Motrin's over-the-counter products since January of 2010. Two recalls were for "a musty or moldy odor" linked to trace amounts of a chemical called 2,4,6-tribromoanisole (TBA); others stemmed from a quality-control issue that may have resulted in excessive amounts of the active ingredient. No major adverse reactions have been reported, although the odorous pills were linked to a few cases of minor gastrointestinal distress.^{[3] [4]}

Flickr: RogueSun Media (Raymond Gilford)
Date of latest recall	December 2011[1]
Originally released	1974[5]
Treats	Minor aches and pains, reduces fever[6]
Administration	Taken by mouth as directed on product package
Reason for recall	Some caplets may not dissolve as quickly as intended when nearing their expiration date.[1]
Disclaimer	The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.

Motrin Recall Timeline

December 21, 2011: Testing of product samples showed that as the affected Motrin approaches its expiration date, the coating may dissolve more slowly. This can cause the medicine to take longer to work. There were no safety concerns for this recall.

Lot numbers include: Motrin IB 24 coated tablets ADA069, ALA168, ALA244, AMA286, APA001, ASA001

Motrin IB 24 coated caplets ACA310, ACA460, ADA407, AEA262, AFA226, AJA170, ALA037, ALA163, AMA012, AMA331, AMA342, APA035, ASA082, ASA123, ASA285, BDA238, BDA260, BDA383, BEA065, BEA148, BEA269, BEA277, BFA064, BFA144, BFA244, BHA078, BHA147, BHA167, BHA198, BJA164, BJA221, BMA144, BMA215, BMA271, BSA022, BSA056, CBA063, CBA107, CCA028, CDA003, CFA065, CFA100, CHA012, CHA044, CHA066, CHA080, CMA028, CMA035, CMA057, CMA102, CMA108

Motrin IB 24+6 coated caplets ACA761, ALA265^[1]

November 15, 2010: McNeil Consumer Healthcare, in conjunction with the FDA, recalled Children's Benadryl Allergy Fastmelt Tablets, and Junior Strength Motrin Caplets, due to issues with the manufacturing process McNeil stated that the products met quality standards. Consumers were not required to return the product.^{[7] [8]}

July 8, 2010: McNeil Consumer Healthcare recalled 21 lots of various medications, including Motrin IB as well as Tylenol. This was the second recall caused by complaints of musty , moldy smell. The odor was linked to the presence of a chemical called 2,4,6-tribromoanisole (TBA), found in the wooden pallets used to ship the product.^[9]

April 30, 2010: Some Infants' and Children's Motrin formulas were recalled because of higher-than-specified levels of the active ingredient. Some products also contained inactive ingredients that did not meet quality-control standards, and others contained small foreign particles. No adverse effects were reported. Consumers were instructed to return or destroy products from the affected lot numbers.^[10]

March 29, 2010: McNeil Consumer Healthcare voluntarily recalled some lots of Infants’ Tylenol, Infants’ Motrin, and Children’s Zyrtec because the products' expiration dates and lot numbers had the tendency to fade with handling. This was a wholesale-level recallm and consumers were not asked to return or destroy the product. No known adverse effects were reported.^[11]

January 15, 2010: Several McNeil Consumer Healthcare products, including some Tylenol, Benadryl, Rolaids, Simply Sleep, and St. Joseph products, as well as several Motrin IB formulations, were recalled due to consumer complaints of "an unusual moldy, musty, or mildew-like odor". This odor caused a minor adverse reactions in a small minority of users, including upset stomach, abdominal pain, and diarrhea.^[4]

The odor was traced to traces of the chemical 2,4,6-tribromoanisole (TBA), which is used to treat wooden pallets used to ship the products. ^{[4] [9]}

Drug Side Effects

About Motrin

Motrin is a brand of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) available in both over-the-counter and prescription formulations. Ibuprofen is an analgesic used for mild to moderate pain from headaches, muscle aches, backaches, toothaches, menstrual cramps, and more. Ibuprofen can also ease the symptoms of osteoarthritis, including pain, swelling, and stiffness, as well as symptoms of ankylosing spondylitis, gouty arthritis, and psoriatic arthritis. It also helps to reduce fever.

Also See: Motrin, Motrin Coupons, Johnson and Johnson Recall, Benadryl Recall, Depuy Hip Implant Recall, Tylenol Recall, Lipitor Recall, Birth Control Recall, Enfamil Recall

References

1. ↑ ^{1.0 1.1 1.2 1.3} http://www.motrin.com/news/7
2. ↑ http://www.cnn.com/2011/12/22/health/motrin-recall/index.html
3. ↑ http://www.motrin.com/news
4. ↑ ^{4.0 4.1 4.2} http://www.mcneilproductrecall.com/page.jhtml?id=/include/press.inc
5. ↑ http://www.motrin.com/1/faq
6. ↑ http://www.motrin.com/product_links/1?val=overview#
7. ↑ http://www.motrin.com/news/1
8. ↑ http://www.fda.gov/Safety/Recalls/ucm235002.htm
9. ↑ ^{9.0 9.1} http://www.motrin.com/news/2
10. ↑ http://www.motrin.com/news/3
11. ↑ http://www.motrin.com/news/4