CLASS II Drug recall · Reported 4 Mar 2015 · FDA Enforcement Report

Mafenide Acetate, USP, For 5% Topical Solution, Sterile recalled

Par Pharmaceutical is recalling Mafenide Acetate, USP, For 5% Topical Solution, Sterile, distributed nationwide in the US. The recall was initiated on 12 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)

Quantity recalled2856 cartons (each containing 5 packets)

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0393-2015
FDA event ID: 70439
Recalling firm: Par Pharmaceutical, Spring Valley, NY
Classification: Class II
Status: Terminated
Recall initiated: 12 Feb 2015
FDA classified: 20 Feb 2015
Reported: 4 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Creams, Ointments & Gels

Timeline

12 Feb 2015	Recall initiated by company
20 Feb 2015	Classified by FDA	+8 days
4 Mar 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene

Product as listed by the FDA

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)

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene

Which lots are affected?

Lots M13012 (exp. date MAR 2015), M13014 (exp. date MAR 2015), M14036 (exp. date FEB 2016), and M14077 (exp. date JUL 2016)

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Par Pharmaceutical

All 17

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