Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01

Recall Number: D-1247-2019

Firm: LUPIN SOMERSET

Classification: Class III

Status: Terminated

Report Date: 20190501

Initiation Date: 20190410

Termination Date: 20221014

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01