Medications & Supplements/Prescription Drugs

HF Acquisition Co. LLC: Famotidine Injection Recalled for Temperature Abuse During Shipping

Agency Publication Date: July 21, 2020

Summary

HF Acquisition Co. LLC is recalling one lot of Famotidine Injection, USP (20 mg/2mL), a prescription medication used to treat stomach and throat issues. The recall was initiated after a customer reported that the product was delivered in a non-refrigerated state instead of the required cold storage conditions. This exposure to improper temperatures, known as temperature abuse, could potentially affect the medication's effectiveness or safety.

Risk

If the medication is not kept at the proper refrigerated temperature, it may lose its potency or degrade, meaning it might not work correctly to treat the patient's condition as intended.

What You Should Do

Check your medication vials for Famotidine Injection, USP, 20 mg/2mL (2 mL single-dose vial) with NDC number 63323-739-12.
Verify if your product belongs to Lot Number 6122639 with an expiration date of 08/2021.
If you identify an affected vial, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use or seek a replacement.
Return any unused product from this specific lot to your pharmacy to receive a refund.
Contact the manufacturer, HF Acquisition Co. LLC, at their Mukilteo, Washington facility for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Famotidine Injection, USP, 20 mg/2mL (2 mL vial)

Model:

NDC 63323-739-12

Recall #: D-1392-2020

Lot Numbers:

6122639 (Exp. Date 08/2021)

Date Ranges: 08/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85916

Status: Resolved

Manufacturer: HF Acquisition Co. LLC

Sold By: consignee

Manufactured In: United States

Distributed To: Connecticut

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for Famotidine Injection, USP, 20 mg/2mL (2 mL single-dose vial) with NDC number 63323-739-12.

Verify if your product belongs to Lot Number 6122639 with an expiration date of 08/2021.

If you identify an affected vial, contact your healthcare provider or pharmacist immediately for guidance on whether to continue use or seek a replacement.

Return any unused product from this specific lot to your pharmacy to receive a refund.

Contact the manufacturer, HF Acquisition Co. LLC, at their Mukilteo, Washington facility for further instructions regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.