D-1214-2018 Class III Terminated
FDA drug recall D-1214-2018 was initiated by LUPIN SOMERSET on August 23, 2018 and is designated Class III. 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 sta… The recall status is terminated (terminated October 14, 2022). Affected quantity: 4716 bottle.
Recall Details
- Product Type
- Drugs
- Report Date
- September 26, 2018
- Initiation Date
- August 23, 2018
- Termination Date
- October 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4716 bottle
Product Description
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.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot# S800232, Exp 2/20