Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Affected NDC
63037-0123-25
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine
- Recalling firm
- Hikma Injectables USA Inc
- NDC code
- 63037-123-25
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0508-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now completed, 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 Hikma Injectables USA Inc
All 2024 recalls
Class II · Moderate risk
phenylephrine in 0.9% Sodium Chloride Inj
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk
ketamine inj 50 mg per 1 mL
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class III · Low risk
Fentanyl 1000mcg/100mL
Labeling: Wrong Barcode
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