Recall archive / FDA drug enforcement

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Onl... — FDA record D-0363-2023

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 Feb 24, 2023. 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 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Reason: Subpotent Drug
Classification: Class III
Recalling firm: SCA Pharmaceuticals
Quantity: 2125 syringes
Agency-reported status: Terminated
Source record identifier: D-0363-2023

Open the official record

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	Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the US.

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: Mar 8, 2023
Recall initiation date: Feb 24, 2023
Center classification date: Feb 28, 2023
Termination date: Jun 21, 2023

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.