Drug product
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
D-0862-2020
Product summary
- Event
- Event 85017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,695 bottles
- Official record key
drug-enforcement:D-0862-2020
Official wording
Reason: Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Code information: Lot #: 1342500A, Exp 10/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
out of specification