FDA Drug recall D-0393-2015
Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label ---…
- FDA Drug
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label ---… by Par Pharmaceutical, citing presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0393-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-12 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Par Pharmaceutical |
| Distribution | US |
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
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Identifiers
| code_info | Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Par Pharmaceutical
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
FDA Drug · Class II · 2020-09-02 · Par Pharmaceutical - Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par F…
FDA Drug · Class II · 2020-04-08 · Par Pharmaceutical - PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
FDA Drug · Class III · 2020-03-25 · Par Pharmaceutical - Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services…
FDA Drug · Class III · 2020-02-19 · Par Pharmaceutical - Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977…
FDA Drug · Class I · 2019-05-15 · Par Pharmaceutical
All Par Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0393-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.