FDA-Drug2018-09-26Class III
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
LUPIN SOMERSET
Hazard
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.
Sold states
U.S.A. Nationwide
Affected count
4716 bottle
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1214-2018Don't want to check this manually?
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