Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
Reported: July 20, 2016 Initiated: January 26, 2016 #D-1436-2016
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Details
- Recalling Firm
- Apotex Scientific, Inc
- Units Affected
- 605,989 (30 ct) bottles
- Distribution
- Nationwide, Alaska, Hawaii, and Puerto Rico.
- Location
- Arlington, TX
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;. Recalled by Apotex Scientific, Inc. Units affected: 605,989 (30 ct) bottles.
Why was this product recalled? ▼
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 20, 2016. Severity: Low. Recall number: D-1436-2016.
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