FDAClass IINovember 27, 2013

Omeprazole Delayed-Release Capsules recall

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

Why was Omeprazole Delayed-Release Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 59627; Expiration Date 02/2014

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
Recalling firm
Kremers Urban Pharmaceuticals, Inc.
Quantity
3867 bottles
Distribution
KY & TN
Recall date
November 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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