Teva Pharmaceuticals USA: Drug Recall
Recall #D-0461-2022 · 01/18/2022
Class II: Risk
Recall Details
- Recall Number
- D-0461-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA
- Status
- Terminated
- Date Initiated
- 01/18/2022
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6205 100-count bottles
Reason for Recall
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Product Description
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
Distribution Pattern
Nationwide in the USA
Other Recalls by Teva Pharmaceuticals USA
- Class II: Risk 01/10/2022
- Class III: Low Risk 01/07/2022
- Class III: Low Risk 01/07/2022
- Class II: Risk 12/31/2021
- Class II: Risk 12/31/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.