FDA recall D-1435-2016

Product

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

Reason for recall

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

Distribution

Nationwide, Alaska, Hawaii, and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2016-01-26

Report date

2016-07-20

Termination date

2022-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1435-2016