Recall
FDAHealthFebruary 6, 2025

SUN PHARMACEUTICAL INDUSTRIES INC — Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun

⚠️ Failed Dissolution Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
February 6, 2025

Nationwide within in the USA.

What's affected?

Product
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
UPC
0363304453010
Lot code
AD16615

Additional details

Lot #: AD16615, Exp. Date 07/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 9840 bottles.

View original FDA notice →

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