FDA-Drug2015-03-04Class II

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)

Par Pharmaceutical Inc.
Hazard

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

Sold states
Nationwide
Affected count
2856 cartons (each containing 5 packets)
Manufactured in
1 RAM Ridge Rd, N/A, Spring Valley, NY, United States
Products
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)

Official notice

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

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