February 2015 FDA Recall Drug by Par Pharmaceutical Inc.
D-0393-2015 - Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene

This Class II drug recall was voluntarily initiated by Par Pharmaceutical Inc. on February 12, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; oxidized steel, organic material and shredded polypropylene. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0393-2015

Reason for Recall
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Initiated
02-12-2015
Reported
03-04-2015
Quantity
2856 cartons (each containing 5 packets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70439
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Par Pharmaceutical Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-02-2017
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

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