D-1246-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2019
- Initiation Date
- April 10, 2019
- Termination Date
- October 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,444 bottles
Product Description
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 for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Code Information
Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.