🔍 RecallPedia

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;

Class I - Dangerous
💊 Drugs Recalled: January 26, 2016 Apotex Scientific Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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, 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;

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1436-2016

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