# FDA recall D-1042-2014

> **Wockhardt Usa Inc.** · Class II · drug recall initiated 2013-11-27.

## Product

Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India.  Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA.  NDC: 64679-0434-02.

## Reason for recall

Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.

## Distribution

Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-1042-2014
- **Recalling firm:** Wockhardt Usa Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-27
- **Report date:** 2014-02-05
- **Termination date:** 2015-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1042-2014

## Citation

> AI Analytics. FDA recall D-1042-2014. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-1042-2014. Source: US FDA. Licensed CC0.

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