LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.…

Recall date

April 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1245-2019

FDA classification

Class III

Brand / firm

LUPIN SOMERSET

Sold / distributed

Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

Why it was recalled

Failed Impurities/Degradation Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01