Drug recall: Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR…

Class II FDA enforcement event 70439. Recall start date: 12 Feb 2015. Status in the FDA record: Terminated. Termination date: 2 May 2017.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Par Pharmaceutical Inc. started this drug recall on 12 Feb 2015. The firm address in the FDA record is in Spring Valley, NY. FDA put the recall in Class II. FDA event 70439 has 1 product record. The first FDA enforcement report date is 4 Mar 2015. The record gives the status Terminated, with the termination date 2 May 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Par Pharmaceutical Inc., Spring Valley, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 70439: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0393-2015	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)	2856 cartons (each containing 5 packets)	Class II	Terminated	4 Mar 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2015: 292
Share of these events in Class II: 52%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of Par Pharmaceutical Inc.
Initiated	Product (first record)	Type	Class	Records
10 Aug 2020	BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01	Drug	Class II	1
30 Mar 2020	Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.	Drug	Class II	1
4 Mar 2020	PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, ND	Drug	Class III	1
10 Feb 2020	Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Alm	Drug	Class III	1
30 Apr 2019	Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestn	Drug	Class I	1
6 Sep 2018	Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: P	Drug	Class III	1
5 Oct 2016	Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in In	Drug	Class II	1
27 Sep 2016	Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (ND	Drug	Class III	5
26 Oct 2015	Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct	Drug	Class III	2
24 Nov 2014	HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, In	Drug	Class II	1

Par Pharmaceutical Inc.: all 11 events

Official channels

FDA enforcement report D-0393-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 70439. https://recallregister.com/fda/ii/70439/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 70439?: The FDA record gives this quantity: 2856 cartons (each containing 5 packets)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2015 have the same class?: 52% of the 292 drug events that started in 2015 are in Class II.