June 2020 FDA Recall Famotidine by Hf Acquisition Co. Llc
D-1392-2020 - TEMPERATURE ABUSE
This Class III drug recall was voluntarily initiated by Hf Acquisition Co. Llc on June 17, 2020 for the product Famotidine. The FDA reported the reason for recall as temperature abuse. The product was distributed in The vials were distributed to one consignee located in CT. and the recall is currently terminated.
Recall Number: D-1392-2020
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
06-17-2020
07-29-2020
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
HF Acquisition Co. LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
The vials were distributed to one consignee located in CT.
04-13-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 6122639, Exp. Date 08/2021
