December 2022 FDA Recall Heparin Sodium by Pfizer Inc.
D-0097-2023 - Lack of assurance of sterility
This Class II drug recall was voluntarily initiated by Pfizer Inc. on December 29, 2022 for the product Heparin Sodium. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0097-2023
Lack of assurance of sterility: Bags have the potential to leak.
12-29-2022
01-11-2023
62,088 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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer 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 in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Batch or Lot Expiration Information
Lot# Lot: 5935283, Exp. 12/01/2023
