Drug product
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108
D-1287-2015
Product summary
- Event
- Event 71717
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,675 cases
- Official record key
drug-enforcement:D-1287-2015
Official wording
Reason: Failed Dissolution Specifications
Code information: a) 13034 exp 10/31/15, 13222 and 13337 exp 11/30/15, 13611 and 13760 exp 2/29/15, 13953 exp 4/30/16, and 14542 exp 1/31/17; b) BT10114001 and BT10115001A exp 2/1/18, 13316 and 13438 exp 11/30/15 and 13880 exp 2/29/16; c) 13298 exp 11/30/15 and 13759 exp 4/30/16
Distribution pattern: Puerto Rico and Virgin Islands
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications