Reported Feb 9, 2022 · Terminated
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only,…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only
- Manufactured byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA
- Distributed byActavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
- Lot codes and dates
Lot# 100025842100028023Exp Date 08/2023
- Amount recalled
- 6205 100-count bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
This product could cause temporary or reversible health problems — stop using it.
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