Recalls / Class II
Class IID-0461-2022
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
- Brand name
- Doxylamine Succinate And Pyridoxine Hydrochloride
- Generic name
- Doxylamine Succinate And Pyridoxine Hydrochloride
- Active ingredients
- Doxylamine Succinate, Pyridoxine Hydrochloride
- Route
- Oral
- NDC
- 0591-2132
- FDA application
- ANDA205811
- Affected lot / code info
- Lot# 100025842, 100028023, Exp Date 08/2023
Why it was recalled
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 6205 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-01-18
- FDA classified
- 2022-01-28
- Posted by FDA
- 2022-02-09
- Terminated
- 2022-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0461-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.