FDAFDA · Food and drugs·Recall number D-0461-2022
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
Published February 9, 2022 · Recall initiated: January 18, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
What to do
Voluntary: Firm initiated
Recall details
- Brand
- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the USA
- Lot
- Lot# 100025842, 100028023, Exp Date 08/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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