Food, drugs, devices › HF Acquisition Co LLC
Drug recall: GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-
HF Acquisition Co LLC (Mukilteo, WA) initiated this drug recall on 6 Jun 2023; FDA lists 1 product record under event 92468, 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. 26% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 27 Feb 2024. 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
"Labeling: Label Mix-up"
Distribution
"Distributed in TX, AZ and CA only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0870-2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3 | 9 boxes of 25 vials | Class III | Terminated | 14 Jun 2023 |
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 |
| 17 Jun 2020 | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Dis | 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: "Labeling: Label Mix-up"
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: "Distributed in TX, AZ and CA only"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Feb 2024. "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.