SCA Pharmaceuticals recalls fentanyl injections due to lack of sterility assurance. This could lead to infections if used improperly. Affected lots expire by November 2023.
Lack of Assurance of Sterility
SCA Pharmaceuticals is recalling fentanyl injections that may not be sterile, which could cause infections if used. This recall affects specific lots with expiration dates up to November 2023.
The product lacks assurance of sterility, meaning it might contain contaminants that could cause infections when injected. This is a serious risk for intravenous use.
People prescribed fentanyl injections by a doctor who received these specific lots are affected. Those using the product without medical supervision are not at risk.
Check the lot number on the packaging: 1223048351 (expires 11/30/23) or 1223048532 (expires 12/07/23). The product is a 50 mL fentanyl injection for IV use only, with NDC 70004-0222-30.
Look for lot numbers 1223048351 (expires 11/30/2023) or 1223048532 (expires 12/07/2023) on the packaging.
The product may not be sterile, so it could cause infections if used. Do not use without checking the lot number.
Check the lot number on the packaging. If it matches the recalled lots, contact your doctor or pharmacist for instructions.
The recalled products expire by November 30, 2023, or December 7, 2023, depending on the lot number.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0396-2024 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0396-2024 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.
