FDA-Drug2016-07-20Class III
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;
Apotex Scientific, Inc
Hazard
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Sold states
Nationwide, Alaska, Hawaii, and Puerto Rico.
Affected count
107,880 (60 ct bottle)
Manufactured in
2100 Rd To Six Flags Dr, Arlington, TX, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1435-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief