Mafenide Acetate — Class II drug recall D-0393-2015
Terminated recall by Par Pharmaceutical Inc., reported 2015-03-04, distributed nationwide. Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
| Recall number | D-0393-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical Inc., Spring Valley, NY, United States |
| Recall initiated | 2015-02-12 |
| Classified | 2015-02-20 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2017-05-02 |
| Distributed | Nationwide (US) |
| NDC | 49884-0902-52, 49884-0902-78 |
| Lot numbers | M13012 |
| Expiration dates | 2015-03-20, 2016-02-20, 2016-07-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0393-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.