Par Pharmaceutical Inc. recalls Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharma
Recalled March 4, 2015 · FDA recall D-0393-2015 · Par Pharmaceutical
Hazard
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene · FDA Class II
Units
2856 cartons (each containing 5 packets)
Sold at
Nationwide
Description
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
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)
Manufacturer(s)
Par Pharmaceutical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →