LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Recalled May 1, 2019 · FDA recall D-1243-2019 · LUPIN SOMERSET
Hazard
Failed Impurities/Degradation Specifications · FDA Class III
Units
17,328 bottles
Sold at
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Description
Failed Impurities/Degradation Specifications
Product
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
Manufacturer(s)
LUPIN SOMERSET
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →