FDA-Drug2022-02-09Class II

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

Teva Pharmaceuticals USA
Hazard

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

Sold states
Nationwide in the USA
Affected count
6205 100-count bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0461-2022

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