Multi-event January 2014 FDA Recall Heparin Sodium by Hospira Inc.
This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on January 9, 2014 for the product Heparin Sodium. The FDA reported the reason for recall as lack of assurance of sterility; potential leakage from administrative port.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1035-2014
Lack of Assurance of Sterility; potential leakage from administrative port.
01-09-2014
02-05-2014
15258 bags
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.
Hospira Inc.
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 including Puerto Rico
05-19-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
Batch or Lot Expiration Information
Lot# : 26-123-JT, Exp: 8/14
Recall Number: D-1036-2014
Lack of Assurance of Sterility; potential leakage from administrative port.
01-09-2014
02-05-2014
27780 bags
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.
Hospira Inc.
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 including Puerto Rico
05-19-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
Batch or Lot Expiration Information
Lot# : 26-125-JT, Exp: 8/14
