Home / Recalls / Kremers Urban Pharmaceuticals, Inc. / D-009-2014

D-009-2014 Class II Terminated

Recalled by Kremers Urban Pharmaceuticals, Inc. — Seymour, IN

Recall Details

Product Type: Drugs
Report Date: November 27, 2013
Initiation Date: September 16, 2013
Termination Date: May 9, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3867 bottles

Product Description

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.

Distribution Pattern

KY & TN

Code Information

Lot Number 59627; Expiration Date 02/2014