Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This
Summary
The FDA issued a Class II for Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, by SSM Health Care St. Louis DBA SSM St. Clare Health Center. Reason: Lack of Assurance of Sterility: Firm did not perform process validation..
Details
Source
Drug Recall
External ID
D-0435-2024
Action Date
2024-04-10
Status
Ongoing
Category
drug
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
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.
Quantity Affected: 11,798 syringes
Reason for Recall
Lack of Assurance of Sterility: Firm did not perform process validation.
Distribution
MO
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-29
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SSM Health Care St. Louis DBA SSM St. Clare Health Center has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SSM Health Care St. Louis DBA SSM St. Clare Health Center) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SSM Health Care St. Louis DBA SSM St. Clare Health Center have FDA actions?
SSM Health Care St. Louis DBA SSM St. Clare Health Center has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0435-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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