Class III
Terminated
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
- Company
- Lupin Somerset
- Recall Initiated
- August 23, 2018
- Posted
- September 26, 2018
- Recall Number
- D-1214-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4716 bottle
- Firm Location
- Somerset, NJ, United States
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.
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot# S800232, Exp 2/20
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