D-1243-2019 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
- 17,328 bottles
Product Description
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
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#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020