D-0249-2025 Class II Ongoing
FDA drug recall D-0249-2025 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on February 6, 2025 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 9840 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 12, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9840 bottles
Product Description
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide within in the USA.
Code Information
Lot #: AD16615, Exp. Date 07/2025