Nationwide Tylenol Recall

AUGUST 15, 2011

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil) is recalling, at the retail and wholesale level, certain lots of products containing TYLENOL® Cold Multi-Symptom Nighttime Rapid Release Gelcaps distributed in the United States and Puerto Rico. This is not a consumer level recall and the risk of any adverse health effects related to the reason for the recall is unlikely.

McNeil is 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 TYLENOL® Cold Multi-Symptom Nighttime Rapid Release Gelcaps. CPAA is a compound formed from the combination of two product ingredients and certain levels are expected in the product.

No safety concerns have been associated with CPAA and it is unlikely to cause an adverse reaction. This action 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

The lot numbers (full product list attached below) for the recalled product can be found on the side of the carton label. Consumers with general questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time). Consumers who have health concerns should contact their healthcare provider.

FULL RECALLED PRODUCT LIST:

TYLENOL® COLD MULTI-SYMPTOM NIGHTTIME RAPID RELEASE GELS 24 RR GELCAPS
Lot Number: AMA277, APA059, APA162, ASA025, APA237, ASA072, ASA208, BAA008
UPC: C300450395245

TYLENOL® COLD MULTI-SYMPTOM RAPID RELEASE GELS DAY/NIGHT 12+8 RR GELCAPS
Lot Number: AMF034, BAF005, BAF027, BCF080
UPC: 300450396204

TYLENOL® COLD MULTI-SYMPTOM RAPID RELEASE GELS DAY/NIGHT 36+24 RR GELCAPS
Lot Number: BBF001, BCF060, BCF079
UPC: 300450396600