November 2019 FDA Recall Dextrose by Pfizer Inc.
D-0577-2020 - Labeling
This Class II drug recall was voluntarily initiated by Pfizer Inc. on November 27, 2019 for the product Dextrose. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0577-2020
Labeling: Incorrect or Missing Lot and/or expiration date.
11-27-2019
12-18-2019
77,100 syringes
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.
Nationwide within the United States including Puerto Rico.
01-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Batch or Lot Expiration Information
Lot# : 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.
