🔍 RecallPedia

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

Class I - Dangerous
💊 Drugs Recalled: October 22, 2014 Prometheus Laboratories Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 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:
Prometheus Laboratories Inc.
Reason for Recall:
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

Product Codes/Lot Numbers:

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0249-2015

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