SCA Pharmaceuticals recalls Fentanyl 500 mcg/250mL injection due to shipment of rejected units. This product is for epidural use only and requires immediate action.
cGMP deviations: due to shipment of rejected units.
SCA Pharmaceuticals is recalling Fentanyl 500 mcg/250mL injection for epidural use because of cGMP deviations from shipment of rejected units. This recall affects patients who may have received this medication and requires immediate attention to ensure safety.
The recall is due to cGMP deviations, meaning the product was shipped after being rejected by quality control. This could potentially lead to unsafe medication if used without proper quality checks.
Patients who have been prescribed this Fentanyl injection for epidural use are affected. Healthcare providers using this product for medical procedures are at higher risk due to the nature of the medication.
Check for the product name 'FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use' with NDC# 70004-0253-40 and Lot # 1223047134. The use-by date is 09/21/2023.
Verify the product name, NDC number, and lot number to confirm if it matches the recalled items.
The recall indicates cGMP deviations, so the product may not be safe. Do not use until you confirm it's not recalled.
Check the product details to see if it matches the recalled items. If it does, contact your healthcare provider for guidance.
The recall record does not specify a replacement process. Contact SCA Pharmaceuticals directly for assistance.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0945-2023 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0945-2023 from SCA Pharmaceuticals. 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.
