Food, drugs, devices › HF Acquisition Co. LLC
Drug recall: Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Dis
HF Acquisition Co. LLC (Mukilteo, WA) initiated this drug recall on 17 Jun 2020; FDA lists 1 product record under event 85916, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 13 Apr 2021. Initiation: voluntary: firm initiated. HF Acquisition Co. LLC has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
HF Acquisition Co. LLC, Mukilteo, WA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1392-2020 | 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 | N/A | Class III | Terminated | 29 Jul 2020 |
Context
Other enforcement events for HF Acquisition Co. LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Apr 2026 | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 | Device | Class II | 2 |
| 11 Dec 2024 | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In | Device | Class II | 1 |
| 6 Jun 2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662- | Drug | Class III | 1 |
| 5 Jun 2020 | STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardi | Device | Class II | 1 |
| 4 Jun 2020 | HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place We | Device | Class II | 4 |
All 6 events for HF Acquisition Co. LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "The vials were distributed to one consignee located in CT."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.