D-0577-2020 Class II Terminated

Recalled by Pfizer Inc. — New York, NY

FDA drug recall D-0577-2020 was initiated by Pfizer Inc. on November 27, 2019 and is designated Class II. Reason for recall: Labeling: Incorrect or Missing Lot and/or expiration date. The recall status is terminated (terminated January 14, 2022). Affected quantity: 77,100 syringes.

Recall Details

Product Type
Drugs
Report Date
December 18, 2019
Initiation Date
November 27, 2019
Termination Date
January 14, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
77,100 syringes

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide within the United States including Puerto Rico.

Code Information

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