Reported Mar 4, 2015 · Terminated
Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR…
Par Pharmaceutical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Par Pharmaceutical Inc. · 1 RAM Ridge Rd · Spring Valley, NY · 10977-6714
Is this the product you have?
- Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals
- label --- Distributed byPar 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)
- Lot codes and dates
Lots M13012 (exp. date MAR 2015)M13014 (exp. date MAR 2015)M14036 (exp. date FEB 2016)and M14077 (exp. date JUL 2016)
- Amount recalled
- 2856 cartons (each containing 5 packets)
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
This product could cause temporary or reversible health problems — stop using it.
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