Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufa
Summary
The FDA issued a Class II for Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/ by Teva Pharmaceuticals USA. Reason: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient.
Details
Source
Drug Recall
External ID
D-0461-2022
Action Date
2022-02-09
Status
Terminated
Category
drug
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
Lot/Code Info: Lot# 100025842, 100028023, Exp Date 08/2023
Quantity Affected: 6205 100-count bottles
Reason for Recall
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-18
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA have FDA actions?
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0461-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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