Drug Enforcement D-0435-2024

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

Status

Ongoing

Classification

Class II

Report Date

April 10, 2024

Termination Date

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Product Information

Product description
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
Product quantity
11,798 syringes
Reason for recall
Lack of Assurance of Sterility: Firm did not perform process validation.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
MO

Location & Firm

Recalling firm
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Address
1015 Bowles Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0435-2024
Event ID
94198
Recall initiation date
February 29, 2024
Center classification date
April 4, 2024
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.
More code info
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