Reported Jul 20, 2016 · Terminated
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto,…
Apotex Scientific, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Scientific, Inc · 2100 Rd To Six Flags Dr · Arlington, TX · 76011
Is this the product you have?
- 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;
- Lot codes and dates
Lot #: KW2167KY9960KV9789KV9788Exp 02/29/2016Lot #: KY9961Exp 04/30/2016Lot #: KX6311KX6312KY7795KX6315Exp 05/31/2016Lot #: KX6317Exp 06/30/2016
- Amount recalled
- 605,989 (30 ct) bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Apotex Scientific, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.