Recall D-1246-2019

Product type

Drugs

Firm

LUPIN SOMERSET

Status

Ongoing

Classification

Class III

Product

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

Reason

Failed Impurities/Degradation Specifications

Distribution

Product was shipped to 5

Report date

2019-05-01