Recalls / Class II
Class IID-0393-2015
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)
- Affected 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)
Why it was recalled
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Recalling firm
- Firm
- Par Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 RAM Ridge Rd, N/A, Spring Valley, New York 10977-6714
Distribution
- Quantity
- 2856 cartons (each containing 5 packets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-12
- FDA classified
- 2015-02-20
- Posted by FDA
- 2015-03-04
- Terminated
- 2017-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0393-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.