🔍 RecallPedia

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

Class I - Dangerous
💊 Drugs Recalled: August 23, 2018 LUPIN SOMERSET Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot# S800232, Exp 2/20
  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:
LUPIN SOMERSET
Reason for Recall:
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

Product Codes/Lot Numbers:

Lot# S800232, Exp 2/20

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1214-2018

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