Reported Jan 8, 2025 · Terminated
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults…
Hikma Injectables USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Injectables USA Inc · 36 Stults Rd · Dayton, NJ · 08810-1540
Is this the product you have?
phenylephrine in 0.9% Sodium Chloride Inj1mg per 10 mL (100 mcg/mL)Rx onlyHikma Injectables USA Inc36 Stults RoadDaytonNJ 08810NDC 63037-173-25
- Lot codes and dates
- Lot number243120003D
- Use by Date03/11/2025
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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