Hikma Injectables USA Inc recalls Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36…
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Read the official notice →- Date
- 2024-05-29
- Country
- United States
- Brand
- Hikma Injectables
- Product
- Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults…
- Classification
- Class I
- Units
- CO, GA, PA, SD, WA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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