Drug recall D-009-2014

Class II Terminated reported Nov 27, 2013

Product

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

Reason for recall

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

Lots and codes

Lot Number 59627; Expiration Date 02/2014

Recall details

Recalling firm
Kremers Urban Pharmaceuticals, Inc., Seymour, IN
Quantity
3867 bottles
Distribution
KY & TN
Type
Voluntary: Firm initiated
Recall initiated
September 16, 2013
Terminated
May 9, 2014

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