September 2013 FDA Recall Omeprazole by Kremers Urban Pharmaceuticals, Inc.
D-009-2014 - Failed Tablet/Capsule Specification
This Class II drug recall was voluntarily initiated by Kremers Urban Pharmaceuticals, Inc. on September 16, 2013 for the product Omeprazole. The FDA reported the reason for recall as failed tablet/capsule specification. The product was distributed in KY & TN and the recall is currently terminated.
Recall Number: 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.
09-16-2013
11-27-2013
3867 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kremers Urban Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
KY & TN
05-09-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot Number 59627; Expiration Date 02/2014
