SCA Pharmaceuticals recalls Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags due to CGMP deviations. These prescription-only products were manufactured in Windsor, CT with specific lot numbers and expiration dates.
CGMP Deviations
SCA Pharmaceuticals is recalling Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags because of manufacturing quality control issues. This recall affects prescription-only products with specific lot numbers and expiration dates.
CGMP deviations refer to failures in the manufacturing process that could affect product safety and quality. These deviations may lead to potential issues with the medication's effectiveness or safety, though the exact risk is not specified in the recall notice.
Prescription holders of these specific Fentanyl and Bupivacaine bags from SCA Pharmaceuticals in Windsor, CT. Healthcare providers and patients using these products are at risk due to the manufacturing deviations.
Check for the product name, 'Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags', which are prescription-only. Look for lot numbers 1222035837 or 1222035804 with expiration dates of July 22, 2022 or July 25, 2022.
Verify the lot number and expiration date on the bag to confirm if it is part of the recall.
The recall is due to CGMP deviations, which are manufacturing quality control issues that may affect product safety and quality.
The recall notice does not specify a remedy, so check the product details to see if it matches the recall criteria.
Look for lot numbers 1222035837 or 1222035804 with expiration dates of July 22, 2022 or July 25, 2022.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0830-2022 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0830-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
