FDA recall D-0393-2015

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-02-12

Report date

2015-03-04

Termination date

2017-05-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Spring Valley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2015