FDA recall D-0069-2021

Product

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.

Reason for recall

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Distribution

Nationwide in the U.S. and PR

Key facts

Status

Terminated

Initiation date

2020-10-28

Report date

2020-11-18

Termination date

2021-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2021