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Recall Observatory FDA recall evidence

Drug product

Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12

D-1392-2020

June 17, 2020

Class III

Product summary

Firm
HF Acquisition Co. LLC
Event
Event 85916
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
drug-enforcement:D-1392-2020

Official wording

Reason: TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

Code information: Lot #: 6122639, Exp. Date 08/2021

Distribution pattern: The vials were distributed to one consignee located in CT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.