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

Recall Number: D-1246-2019

Firm: LUPIN SOMERSET

Classification: Class III

Status: Terminated

Report Date: 20190501

Initiation Date: 20190410

Termination Date: 20221014

Failed Impurities/Degradation Specifications

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