Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use O...

FDA Recall #D-1392-2020 — Class III — June 17, 2020

Recall #D-1392-2020 Date: June 17, 2020 Classification: Class III Status: Terminated

Product Description

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.

Recalling Firm

HF Acquisition Co. LLC — Mukilteo, WA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

The vials were distributed to one consignee located in CT.

Code Information

Lot #: 6122639, Exp. Date 08/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated