FDA-Drug2025-03-12Class II

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Dissolution Specifications

Sold states
Nationwide within in the USA.
Affected count
9840 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2025

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