Recall archive / FDA drug enforcement

PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Sy... — FDA record D-0414-2024

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 9, 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: PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
Reason: Lack of Assurance of Sterility
Classification: Class II
Recalling firm: SCA Pharmaceuticals, LLC
Quantity: 33,072 syringes; expanded 9,041 syringes
Agency-reported status: Terminated
Source record identifier: D-0414-2024

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 #: 1223045536 Exp 12/06/23; 1223045710 Exp 12/10/23; 1223046574 Exp 01/12/24; 1223047579 Exp 02/21/24; 1223047764 Exp 03/06/24; 1223048363 Exp 03/30/24; 1223048364 Exp 03/30/24; 1223048566 Exp 04/06/24; 1223048573 Exp 04/07/24; 1223048574 Exp 04/07/24; 1223048643 Exp 04/11/24; 1223048697 Exp 04/12/24; 1223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/2024; 1223048395, 1223048397, Exp 03/27/2024; 1223049980, Exp 06/05/2024

Label field

Details supplied by the agency

Lot, code or applicability

Lot #: 1223045536 Exp 12/06/23; 1223045710 Exp 12/10/23; 1223046574 Exp 01/12/24; 1223047579 Exp 02/21/24; 1223047764 Exp 03/06/24; 1223048363 Exp 03/30/24; 1223048364 Exp 03/30/24; 1223048566 Exp 04/06/24; 1223048573 Exp 04/07/24; 1223048574 Exp 04/07/24; 1223048643 Exp 04/11/24; 1223048697 Exp 04/12/24; 1223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/2024; 1223048395, 1223048397, Exp 03/27/2024; 1223049980, Exp 06/05/2024

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

Distribution

Nationwide in the USA

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: Apr 3, 2024
Recall initiation date: Nov 9, 2023
Center classification date: Mar 22, 2024
Termination date: Aug 27, 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.