May 2013 FDA Recall Drug by Fresenius Kabi Usa, Llc
D-688-2013 - Failed Impurities/Degradation Specification

This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on May 21, 2013 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-688-2013

Reason for Recall
Failed Impurities/Degradation Specification
Initiated
05-21-2013
Reported
07-17-2013
Quantity
80,480 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65213
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, LLC
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2015
Product Description About Product Description
Full technical description of the product.
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11

Batch or Lot Expiration Information

Lot# : 6103883, Exp 10/2013