October 2013 FDA Recall Albuterol Sulfate by Nephron Pharmaceuticals Corp.
D-66462-001 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Nephron Pharmaceuticals Corp. on October 2, 2013 for the product Albuterol Sulfate. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-66462-001

Reason for Recall
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Initiated
10-02-2013
Reported
10-30-2013
Quantity
689,568 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66462
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2015
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25

Batch or Lot Expiration Information

Lot# Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15

Affected Packages Involved in this Recall

0487-9501-25 Albuterol Sulfate
0487-9501-03 Albuterol Sulfate
0487-9501-60 Albuterol Sulfate
0487-9501-01 Albuterol Sulfate