Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Phenylephrine HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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 NDC
60652-0104-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0435-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center
All 2024 recalls
Class II · Moderate risk
FentaNYL citrate
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility
Class II · Moderate risk
Succinylcholine chloride 100 mg in 5 mL syringe
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
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