Duloxetine Delayed-Release Capsules recall: Failed Dissolution
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;
Why was Duloxetine Delayed-Release Capsules recalled?
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.
- Product
- 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;
- Recalling firm
- Apotex Scientific, Inc
- Quantity
- 605,989 (30 ct) bottles
- Distribution
- Nationwide, Alaska, Hawaii, and Puerto Rico.
- Recall date
- July 20, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)