Doxylamine Succinate And Pyridoxine Hydrochloride Tablet, Delayed Release
FDA Recall NDC 0591-2132
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxylamine Succinate And Pyridoxine Hydrochloride (NDC 0591-2132). A significant event, classified as Class II, was initiated on Jan 18, 2022 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Jan 18, 2022
Feb 09, 2022
6205 100-count bottles
Recall Profile & Regulatory Data
Event ID
89422
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 21, 2022
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
Batch or Lot Expiration Information
Lot# 100025842, 100028023, Exp Date 08/2023
Affected Packages Involved in this Recall
0591-2132-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
