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

Code information: Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.

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