Drug recall D-1243-2019
Product
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
Reason for recall
Failed Impurities/Degradation Specifications
Lots and codes
Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Recall details
- Recalling firm
- LUPIN SOMERSET, Somerset, NJ
- Quantity
- 17,328 bottles
- Distribution
- Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 10, 2019
- Terminated
- October 14, 2022
Related products
- Morphine Sulfate – drug information
- NDC 43386-541 Morphine Sulfate · Morphine Sulfate 30 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-540 Morphine Sulfate · Morphine Sulfate 15 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-543 Morphine Sulfate · Morphine Sulfate 100 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-542 Morphine Sulfate · Morphine Sulfate 60 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-544 Morphine Sulfate · Morphine Sulfate 200 mg/1 · Lupin Pharmaceuticals,Inc.