FDA-Drug2019-05-01Class III

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

LUPIN SOMERSET
Hazard

Failed Impurities/Degradation Specifications

Sold states
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Affected count
3,444 bottles
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1246-2019

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