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
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, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
Affected NDC
70324-0901-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine
- Recalling firm
- SterRx, LLC
- NDC code
- 70324-901-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0324-2022 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 SterRx, LLC
All 2021 recalls
Class II · Moderate risk
Norepinephrine 32 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 16 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 4 mg per 250 mL
Lack of Assurance of Sterility
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