Another Tylenol recall
The McNeil Consumer Healthcare Division plant in Fort Washington closed in April 2010 because of manufacturing problems, but the recalls of products made before then continue.
The McNeil Consumer Healthcare Division plant in Fort Washington closed in April 2010 because of manufacturing problems, but the recalls of products made before then continue.
The company said Monday that it was recalling certain lots of products containing Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps that were distributed in the United States and Puerto Rico.
A spokeswoman said the batches were manufactured at the Fort Washington site, before it was closed, or at the company's facility in Puerto Rico, which is still operating.
Both plants, along with one in Lancaster, were cited for problems during an investigation by the U.S. Food and Drug Administration. McNeil is a division of Johnson & Johnson Inc.
This is the fifth recall of McNeil products in 2011. Most this year involved some version of Tylenol, but particular batches of Benadryl and Sudafed also had problems. Consumers can get more information on each at www.mcneilproductrecall.com.
The company's statement said the latest recall notice was aimed at retailers and wholesalers, where those product lots would likely be located.
McNeil said it was initiating the recall as a precaution after determining, through monitoring of product samples, that the level of a compound contained in the product, known as chlorpheniramine ammonio acetate (CPAA), was slightly higher than expected in some of the gelcaps. CPAA is a compound formed from the combination of two product ingredients and certain levels are expected in the product. McNeil said that no safety concerns have been associated with CPAA and that the recall was not caused by any adverse events. It said consumers could continue to use the product.
The lot numbers and UPC code are on the side of the carton. They are: Tylenol Cold Multi-Symptom Nighttime Rapid Release Gels 24 RR Gelcaps (AMA277, APA059, APA162, ASA025, APA237, ASA072, ASA208, BAA008; UPC - 300450395245); Tylenol Cold Multi-Symptom Rapid Release Gels Day/night 12+8 RR Gelcaps (AMF034, BAF005, BAF027, BCF080; UPC - 300450396204) and Tylenol Cold Multi-Symptom Rapid Release Gels Day/night 36+24 RR Gelcaps (BBF001, BCF060, BCF079; UPC - 300450396600).