Par Pharmaceutical Recalls Mafenide Acetate Topical Solution Due to Foreign Substances
Par Pharmaceutical Inc. is recalling Mafenide Acetate 5% Topical Solution packets due to the presence of oxidized steel, organic material, and shredded polypropylene.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of oxidized steel and shredded polypropylene in a sterile topical solution poses a significant risk of injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
Par Pharmaceutical Inc. is recalling specific lots of Mafenide Acetate, USP, For 5% Topical Solution, sterile, 50 grams per packet. The recall involves 2,856 cartons, each containing five 50-gram packets, which were distributed nationwide. The affected lots are M13012 (expiration date MAR 2015), M13014 (expiration date MAR 2015), M14036 (expiration date FEB 2016), and M14077 (expiration date JUL 2016).
The recall was initiated because the product contains foreign substances, specifically oxidized steel, organic material, and shredded polypropylene. The product is a prescription-only medication manufactured in India and distributed by Par Pharmaceutical Companies, Inc. in Spring Valley, NY.
Healthcare providers and patients should check their inventory for the specific NDC numbers 49884-902-52 and 49884-902-78 and the lot numbers listed above. If these products are found, they should be discontinued and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- 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 4988
- Manufacturer
- Par Pharmaceutical Inc.
- Category
- Drug — Topical Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots M13012 (exp. date MAR 2015)
- M13014 (exp. date MAR 2015)
- M14036 (exp. date FEB 2016)
- and M14077 (exp. date JUL 2016)
Distribution
Distributed nationwide across the United States.
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