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;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Apotex Scientific, Inc
- Reason for Recall:
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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;
Product Codes/Lot Numbers:
Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1435-2016
Related Recalls
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.