Food, drugs, devices › OurPharma LLC
Drug recall: FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPha
OurPharma LLC (Fayetteville, AR) initiated this drug recall on 13 Jan 2023; FDA lists 1 product record under event 91520, 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 20 Sep 2024. Initiation: voluntary: firm initiated. OurPharma LLC has 4 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
OurPharma LLC, Fayetteville, AR.
Reason for recall
"Short Fill: Underfilled units."
Distribution
"IL and MO"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0172-2023 | FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01. | 768 cassettes | Class III | Terminated | 1 Feb 2023 |
Context
Other enforcement events for OurPharma LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Sep 2026 | fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City L | Drug | Class II | 1 |
| 15 Apr 2025 | HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake | Drug | Class III | 1 |
| 29 Nov 2022 | FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repa | Drug | Class II | 1 |
All 4 events for OurPharma LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Short Fill: Underfilled units."
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: "IL and MO"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Sep 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.