Recall: D-1214-2018

Class III - Minor Violations

Class IIIClassification

2018-08-23Initiated

TerminatedStatus

LUPIN SOMERSETFirm

Product

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

Reason

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.

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.