FDA recall D-0862-2020

Product

Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count 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: Low out of specification dissolution result observed during stability testing.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2020-02-20

Report date

2020-03-11

Termination date

2020-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0862-2020