New England Life Care, Inc., doing business as Advanced Compounding Solutions, has recalled 198 bags of Phenylephrine HCl Injection (20 mg added to 250mL bags). The medication was accidentally compounded using 5% Dextrose instead of the required 0.9% Sodium Chloride. This prescription medication is distributed to hospitals and healthcare facilities nationwide. No injuries or adverse events have been reported to date regarding this mix-up.
Patients receiving this injection would be administered a dextrose solution instead of a saline solution. This error could cause unintended health complications for patients who require strict blood sugar management or specific sodium levels. Because the product is an injection, any compounding error carries a risk to the patient's immediate safety.
Clinical/hospital-administered drug return
Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride.
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Sources: FDA iRES · Raw API Response
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