Recalls / Class II

Class IID-0435-2024

Product

Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1

Affected lot / code info

Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.

Why it was recalled

Lack of Assurance of Sterility: Firm did not perform process validation.

Recalling firm

Firm

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1015 Bowles Ave, Fenton, Missouri 63026-2394

Distribution

Quantity

11,798 syringes

Distribution pattern

MO

Timeline

Recall initiated

2024-02-29

FDA classified

2024-04-04

Posted by FDA

2024-04-10

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0435-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.