Recall archive / FDA drug enforcement
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, R... — FDA record D-0078-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
- Reason
- Underfilled units.
- Classification
- Class II
- Recalling firm
- OurPharma LLC
- Quantity
- 691 cassettes
- Agency-reported status
- Terminated
- Source record identifier
- D-0078-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MO
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 21, 2022
- Recall initiation date
- Nov 29, 2022
- Center classification date
- Dec 9, 2022
- Termination date
- Sep 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.