Hikma Injectables USA recalls phenylephrine injection (1mg/10mL) due to potential contamination from tamper-evident seal issues. Affected units have specific lot numbers and use-by dates.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA is recalling phenylephrine injections that may have contamination risks due to tamper-evident seal problems. This could lead to infections if the medication is used without proper sterility.
The tamper-evident seal on some syringes wasn't properly attached during shipping, which could allow contamination. This creates a risk of infection if the medication is used without proper sterility.
Prescription patients using phenylephrine injections for medical purposes. Those with the specific lot number 243120003D and use-by date 03/11/2025 are most at risk.
Check for lot number 243120003D and use-by date 03/11/2025 on the packaging. The product is a prescription phenylephrine injection (1mg per 10 mL) sold by Hikma Injectables USA.
Look for lot number 243120003D and use-by date 03/11/2025 on the packaging.
The recall indicates potential contamination risk due to tamper-evident seal issues, so it is not recommended for use until the recall is addressed.
Check for lot number 243120003D and use-by date 03/11/2025 on the packaging.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to use or discard the product.
We’ve drafted a message you can send Hikma Injectables to request your refund or repair — edit it as you like.
Subject: Recall D-0174-2025 — Hikma Injectables Hikma Injectables Hello, I own a Hikma Injectables that is covered by recall D-0174-2025 from Hikma Injectables. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
