August 2015 FDA Recall Ipratropium Bromide And Albuterol Sulfate by Nephron Pharmaceuticals Corp.
D-0010-2016 - Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

This Class II drug recall was voluntarily initiated by Nephron Pharmaceuticals Corp. on August 21, 2015 for the product Ipratropium Bromide And Albuterol Sulfate. The FDA reported the reason for recall as lack of assurance of sterility; potential exposure to non-sterile lubricant during the filling process. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0010-2016

Reason for Recall
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Initiated
08-21-2015
Reported
10-21-2015
Quantity
a) 85,248 cartons and b) 35,292 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72099
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.
Nephron Pharmaceuticals Corp.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2017
Product Description About Product Description
Full technical description of the product.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL

Batch or Lot Expiration Information

Lot# a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016

Affected Packages Involved in this Recall

0487-0201-01 Ipratropium Bromide And Albuterol Sulfate
0487-0201-02 Ipratropium Bromide And Albuterol Sulfate
0487-0201-03 Ipratropium Bromide And Albuterol Sulfate
0487-0201-60 Ipratropium Bromide And Albuterol Sulfate