Recall archive / FDA drug enforcement

PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture P... — FDA record D-0727-2023

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 Apr 28, 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 added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification: Class II
Recalling firm: Central Admixture Pharmacy Services, Inc.
Quantity: 5304 bags
Agency-reported status: Terminated
Source record identifier: D-0727-2023

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 # 37-883924, Exp 05/02/2023; 37-884918, Exp 05/07/2023; 37-885677, Exp 05/09/2023; 37-887318, Exp 05/16/2023; 37-889211, Exp 05/23/2023; 37-889848, Exp 05/25/2023; 37-891150, Exp 05/31/2023; 37-892482, Exp 06/06/2023; 37-894484, Exp 06/13/2023; 37-896458, 37-896480, Exp 06/21/2023; 37-897967, Exp 06/27/2023; 37-898551, Exp 06/29/2023

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: May 31, 2023
Recall initiation date: Apr 28, 2023
Center classification date: May 19, 2023
Termination date: Jun 22, 2025

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.