November 2021 FDA Recall Dextrose by Pfizer Inc.
D-0265-2022 - Lack of sterility assurance
This Class II drug recall was voluntarily initiated by Pfizer Inc. on November 30, 2021 for the product Dextrose. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0265-2022
Lack of sterility assurance: bag has the potential to leak.
11-30-2021
12-08-2021
765 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.
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.
USA Nationwide
07-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Batch or Lot Expiration Information
Lot# Lot: 4923608 Exp. 1MAY2022
