Drug recall D-1214-2018
Product
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
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.
Lots and codes
Lot# S800232, Exp 2/20
Recall details
- Recalling firm
- LUPIN SOMERSET, Somerset, NJ
- Quantity
- 4716 bottle
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 23, 2018
- 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.