FDA recall D-0461-2022

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-01-18

Report date

2022-02-09

Termination date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

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