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
- Brand
- MORPHINE SULFATE
- 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.
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