D-0461-2022 Class II Terminated
FDA drug recall D-0461-2022 was initiated by Teva Pharmaceuticals USA on Jan 18, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient The recall status is terminated (terminated Dec 21, 2022). Affected quantity: 6205 100-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 18, 2022
- Termination Date
- Dec 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6205 100-count bottles
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
Reason for Recall
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 100025842, 100028023, Exp Date 08/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0461-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026