# FDA recall D-009-2014

> **Kremers Urban Pharmaceuticals, Inc.** · Class II · drug recall initiated 2013-09-16.

## 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

## 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

KY & TN

## Key facts

- **Recall number:** D-009-2014
- **Recalling firm:** Kremers Urban Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-16
- **Report date:** 2013-11-27
- **Termination date:** 2014-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seymour, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-009-2014

## Citation

> AI Analytics. FDA recall D-009-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-009-2014. Source: US FDA. Licensed CC0.

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