LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc.…

Recall date

August 23, 2018

Source

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

Recall number

D-1214-2018

FDA classification

Class III

Brand / firm

LUPIN SOMERSET

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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.

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

What was recalled

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