FDAFDA · Food and drugs·Recall number D-1246-2019
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01
Published May 1, 2019 · Recall initiated: April 10, 2019
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MORPHINE SULFATE
- Manufacturer
- LUPIN SOMERSET
- Distributor
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- UPC
- 0343386542017
- Lot
- Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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