D-0393-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 4, 2015
- Initiation Date
- February 12, 2015
- Termination Date
- May 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2856 cartons (each containing 5 packets)
Product Description
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 Pattern
Nationwide
Code Information
Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)