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
Reason for recall: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Recall initiated: 20220118
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated