SCA Pharmaceuticals recalls fentanyl injection products due to lack of sterility assurance. This may cause infections if used improperly. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
SCA Pharmaceuticals is recalling fentanyl injections that may not be sterile, posing infection risks. This recall affects medical use only, and patients should not use the product without consulting their healthcare provider.
The product lacks sterility assurance, meaning it could be contaminated with bacteria. If used improperly, this contamination could lead to infections, especially in medical settings where sterile procedures are critical.
This recall affects patients prescribed fentanyl injections for medical use. Healthcare providers and patients using the product are most at risk due to potential infection.
Check for the product name: Fentanyl 200 mcg/100 mL with Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection. Look for the lot number 1223048855 and expiration date 12/6/23 on the packaging.
Verify the product name, lot number 1223048855, and expiration date 12/6/23 on the packaging.
The product lacks sterility assurance, so it may be contaminated. Do not use without consulting your healthcare provider.
Contact SCA Pharmaceuticals at 755 Rainbow Rd., Windsor, CT 06095 for details on the recall and next steps.
The recall record does not specify a remedy, so the product should not be used until further instructions are provided.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0397-2024 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0397-2024 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.
