D-0393-2015 Class II Terminated
FDA drug recall D-0393-2015 was initiated by Par Pharmaceutical Inc. on February 12, 2015 and is designated Class II. Reason for recall: Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene The recall status is terminated (terminated May 2, 2017). Affected quantity: 2856 cartons (each containing 5 packets).
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)