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)
Reported: March 4, 2015 Initiated: February 12, 2015 #D-0393-2015
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
Details
- Recalling Firm
- Par Pharmaceutical Inc.
- Units Affected
- 2856 cartons (each containing 5 packets)
- Distribution
- Nationwide
- Location
- Spring Valley, NY
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Par Pharmaceutical Inc.. Units affected: 2856 cartons (each containing 5 packets).
Why was this product recalled? ▼
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 4, 2015. Severity: Moderate. Recall number: D-0393-2015.
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