Recall: D-0461-2022

Class II - Potentially Harmful

Class IIClassification

2022-01-18Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

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

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.