January 2022 FDA Recall Doxylamine Succinate And Pyridoxine Hydrochloride by Teva Pharmaceuticals Usa
D-0461-2022 - Failed Dissolution Specification

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on January 18, 2022 for the product Doxylamine Succinate And Pyridoxine Hydrochloride. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0461-2022

Reason for Recall
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Initiated
01-18-2022
Reported
02-09-2022
Quantity
6205 100-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89422
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-21-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 100025842, 100028023, Exp Date 08/2023

Affected Packages Involved in this Recall

0591-2132-01 Doxylamine Succinate And Pyridoxine Hydrochloride