McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil) is
voluntarily 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:
|
Product Name |
Lot Number |
UPC Code |
|
TYLENOL® COLD MULTI-SYMPTOM NIGHTTIME RAPID RELEASE GELS 24 RR GELCAPS |
AMA277, APA059, APA162, ASA025, APA237, ASA072, ASA208, BAA008 |
300450395245 |
|
TYLENOL® COLD MULTI-SYMPTOM RAPID RELEASE GELS DAY/NIGHT 12+8 RR GELCAPS |
AMF034, BAF005, BAF027, BCF080 |
300450396204 |
|
TYLENOL® COLD MULTI-SYMPTOM RAPID RELEASE GELS DAY/NIGHT 36+24 RR GELCAPS |
BBF001, BCF060, BCF079 |
300450396600 |
