# FDA recall D-1513-2014

> **Wockhardt Usa Inc.** · Class III · drug recall initiated 2014-07-14.

## Product

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

## Reason for recall

Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1513-2014
- **Recalling firm:** Wockhardt Usa Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-14
- **Report date:** 2014-08-13
- **Termination date:** 2015-01-12

- **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-1513-2014

## Citation

> AI Analytics. FDA recall D-1513-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1513-2014. Source: US FDA. Licensed CC0.

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