Class II
Terminated
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)
- Company
- Par Pharmaceutical Inc.
- Recall Initiated
- February 12, 2015
- Posted
- March 4, 2015
- Recall Number
- D-0393-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2856 cartons (each containing 5 packets)
- Firm Location
- Spring Valley, NY, United States
Reason for Recall
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Distribution
Nationwide
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)
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