January 2014 FDA Recall Heparin Sodium by Fresenius Kabi Usa, Llc
D-1148-2014 - Subpotent; 18 month time point
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on January 22, 2014 for the product Heparin Sodium. The FDA reported the reason for recall as subpotent; 18 month time point. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1148-2014
Subpotent; 18 month time point
01-22-2014
03-12-2014
161,650 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-24-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
Batch or Lot Expiration Information
Lot# Lot Number: 6004137, Expiration date: 06/2014
