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
Reported: November 27, 2013 Initiated: September 16, 2013 #D-009-2014
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.
Details
- Recalling Firm
- Kremers Urban Pharmaceuticals, Inc.
- Units Affected
- 3867 bottles
- Distribution
- KY & TN
- Location
- Seymour, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Kremers Urban Pharmaceuticals, Inc.. Units affected: 3867 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2013. Severity: Moderate. Recall number: D-009-2014.
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