Drug product
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
D-0461-2022
Product summary
- Event
- Event 89422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6205 100-count bottles
- Official record key
drug-enforcement:D-0461-2022
Official wording
Reason: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Code information: Lot# 100025842, 100028023, Exp Date 08/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification