D-0249-2025 Class II Ongoing

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

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