Over-the-counter medicines Tylenol, Motrin and Benadryl are being recalled by Johnson & Johnson. This is an expansion of the company’s recall in late April 2010.
The specific medications being recalled are: Children’s Tylenol, Tylenol Extra Strength, Tylenol Day & Night, Tylenol PM, Motrin IB, and adult-strength Benadryl. They were sold in the United States, Puerto Rico, the Dominican Republic, Jamaica, Trinidad & Tobago, Fiji, and Guatemala. 21 Specific lots of product are included in this recall. The lot number can be found on the side of the medication bottle and the recalled lot numbers are specified here: Learn about the lot numbers
McNeil Consumer Healthcare is the division of Johnson & Johnson handling this matter. They are advising customers who bought any of these products to stop using them and contact them for how to obtain a refund or replacement. They can be reached at 1-888-222-6036 or at www.mcneilproductrecall.com.
This recall is the latest in a series of voluntary recalls for Johnson & Johnson. The first recall in November 2009 was for select shipments of Tylenol Arthritis Pain 100 count with EZ-open cap, which had an unusual moldy odor and had some effects of nausea, stomach pain, vomiting, and diarrhea. In December 2009 and January 2010, the recall was expanded to all shipments of the drug and then to other drugs (mostly children's non-prescription medications) from the same plant.
An FDA investigation found no bacterial contamination in any finished lots of medication tested. They did find trace amounts of “tiny metal particles”, and the source of the moldy odor was traced to chemicals in the wooden pallets the medications were stored on. The latest recall is the rest of the medication that was stored on those pallets, according to company officials. The McNeil plant in Fort Washington, Pennsylvania has had production suspended while all safety concerns are addressed.
The FDA is continuing to investigate with their Crime Division, and criminal charges may be made resulting from findings that safety processes were below standards and slow reactions to customer reports of problems. CNN Money Report
Days prior to this recall, McNeil had announced they expect shortages of Tylenol and other drugs for the rest of 2010, especially the children’s medications made at the Fort Washington plant. It is unknown if this recall will cause further shortages or if it was part of their prior estimate.
Tylenol, with the active ingredient acetaminophen, is one of the most effective non-prescription medications for lower back pain and is one of the most common treatments used by back pain patients. Given a potential shortage, patients may consider discussing alternative medicines to Tylenol with their doctors that would be appropriate for their individual health needs including interaction with any other medicines being taken.