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 (packe

FDA recall notice · announced March 4, 2015 · Par Pharmaceutical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)
Quantity: 2856 cartons (each containing 5 packets)
Status: Terminated
Products in this recall event:
- 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 Va (D-0393-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.