June 2013 FDA Recall Drug by Fresenius Kabi Usa, Llc
D-804-2013 - Subpotent Drug; 15-month stability test station

This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on June 24, 2013 for the product Drug. The FDA reported the reason for recall as subpotent drug; 15-month stability test station. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-804-2013

Reason for Recall
Subpotent Drug; 15-month stability test station
Initiated
06-24-2013
Reported
07-24-2013
Quantity
221,600 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65512
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.
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.
04-07-2015
Product Description About Product Description
Full technical description of the product.
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.

Batch or Lot Expiration Information

Lot# : 6003648, Exp. 6/2013