FDA-Drug2013-11-27Class II

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43

Kremers Urban Pharmaceuticals, Inc.
Hazard

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Sold states
KY & TN
Affected count
3867 bottles
Manufactured in
1101 C Ave W, Seymour, IN, United States
Products
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-009-2014

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