Recalls / Class II
Class IID-009-2014
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
- Brand name
- Omeprazole
- Generic name
- Omeprazole
- Active ingredient
- Omeprazole
- Route
- Oral
- NDCs
- 62175-114, 62175-118, 62175-136
- FDA application
- ANDA075410
- Affected lot / code info
- Lot Number 59627; Expiration Date 02/2014
Why it was recalled
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Recalling firm
- Firm
- Kremers Urban Pharmaceuticals, Inc.
- Manufacturer
- Lannett Company, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 1101 C Ave W, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 3867 bottles
- Distribution pattern
- KY & TN
Timeline
- Recall initiated
- 2013-09-16
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2014-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-009-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.