Famotidine Injection recalled over temperature-control failures

Recall date

June 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

HF Acquisition Co. LLC recalls Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Di…

Recall number

D-1392-2020

FDA classification

Class III

Brand / firm

HF Acquisition Co. LLC

Sold / distributed

The vials were distributed to one consignee located in CT.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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