Drug 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)
D-0393-2015
Product summary
- Event
- Event 70439
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2856 cartons (each containing 5 packets)
- Official record key
drug-enforcement:D-0393-2015
Official wording
Reason: Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Code information: Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance