# FDA recall D-0393-2015

> **Par Pharmaceutical Inc.** · Class II · drug recall initiated 2015-02-12.

## Product

Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977  Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)

## Reason for recall

Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0393-2015
- **Recalling firm:** Par Pharmaceutical Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-12
- **Report date:** 2015-03-04
- **Termination date:** 2017-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Spring Valley, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2015

## Citation

> AI Analytics. FDA recall D-0393-2015. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0393-2015. Source: US FDA. Licensed CC0.

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