FDA recall D-1392-2020

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

Reason for recall

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

Distribution

The vials were distributed to one consignee located in CT.

Key facts

Status

Terminated

Initiation date

2020-06-17

Report date

2020-07-29

Termination date

2021-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mukilteo, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1392-2020