FDA-Drug2022-10-05Class III
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Sold states
Nationwide in the USA
Affected count
5712 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2023Don't want to check this manually?
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