Drug Enforcement D-009-2014

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

Status

Terminated

Classification

Class II

Report Date

November 27, 2013

Termination Date

May 9, 2014

Product Information

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
Product quantity
3867 bottles
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.
Recall initiation reason
—
Initial firm notification
—
Distribution pattern
KY & TN

Location & Firm

Recalling firm
Kremers Urban Pharmaceuticals, Inc.
Address
1101 C Ave W

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-009-2014
Event ID
66218
Recall initiation date
September 16, 2013
Center classification date
November 20, 2013
Code info
Lot Number 59627; Expiration Date 02/2014
More code info
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