Par Pharmaceutical Inc. recalls Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharm…

Recall date

February 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0393-2015

FDA classification

Class II

Brand / firm

Par Pharmaceutical Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)