drugs Class II Updated 2015-03-04

Par Pharmaceutical Inc. recalls Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net

Recalled 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)

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)
View official government recall

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