FDAFDA · Food and drugs·Recall number D-1435-2016
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;
Published July 20, 2016 · Recall initiated: January 26, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Scientific, Inc
- Distributor
- Nationwide, Alaska, Hawaii, and Puerto Rico.
- Lot
- Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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