Recall: D-1246-2019

Class III - Minor Violations

Class IIIClassification

2019-04-10Initiated

TerminatedStatus

LUPIN SOMERSETFirm

Product

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

Reason

Failed Impurities/Degradation Specifications

Distribution

Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

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