FDAFDA · Food and drugs·Recall number D-1214-2018
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
Published September 26, 2018 · Recall initiated: August 23, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MORPHINE SULFATE
- Manufacturer
- LUPIN SOMERSET
- Distributor
- U.S.A. Nationwide
- UPC
- 0343386542017
- Lot
- Lot# S800232, Exp 2/20
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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