FDAClass IIDecember 18, 2019

25% Dextrose Injection recall: Labeling Error

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

Why was 25% Dextrose Injection recalled?

Labeling: Incorrect or Missing Lot and/or expiration date.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.

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
Recalling firm
Pfizer Inc.
Quantity
77,100 syringes
Distribution
Nationwide within the United States including Puerto Rico.
Recall date
December 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls