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Recall Observatory FDA recall evidence

Drug 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

D-0577-2020

November 27, 2019

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 84366
Status
Terminated
Classification
Class II
Quantity
77,100 syringes
Official record key
drug-enforcement:D-0577-2020

Official wording

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

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

Distribution pattern: Nationwide within the United States including Puerto Rico.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing