Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: J2022G, Exp: 01/01/2025
  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:
Preferred Pharmaceuticals, Inc.
Reason for Recall:
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Product Codes/Lot Numbers:

Lot #: J2022G, Exp: 01/01/2025

Distribution:

Distributed in: CA, FL, OK, KS, CT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0505-2024

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