SCA Pharmaceuticals recalls labetalol HCl 20mg/4mL injection (NDC 70004-0700-28) due to lack of sterility assurance. This medication is prescription-only and may pose infection risks if used.
Lack of Assurance of Sterility
SCA Pharmaceuticals has recalled labetalol HCl 20 mg/4mL injection due to a lack of sterility assurance. This means the product could cause infections if used improperly. People with prescriptions for this medication should check their product details and contact their healthcare provider.
The injection lacks proper sterility assurance, meaning it could contain harmful bacteria or other contaminants. If used, this could lead to infections, especially in individuals with weakened immune systems or open wounds.
Prescription patients who have received this specific labetalol injection. Those with medical conditions requiring this medication are most at risk.
Check for the product name 'labetalol HCl 20 mg/4mL Injection' with NDC 70004-0700-28. The lot numbers 1223047334 (expiring 12/23/23) and 1223048170 (expiring 02/01/24) are also associated with this recall.
Verify the product name, NDC number, and lot numbers to confirm if your injection is part of this recall.
The recall indicates a lack of sterility assurance, so it is not safe to use. Contact your healthcare provider for guidance.
Check the product name, NDC number (70004-0700-28), and lot numbers (1223047334 or 1223048170) to confirm if your injection is part of this recall.
The recall does not specify a remedy, so contact your healthcare provider for advice on safe handling or disposal.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0411-2024 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0411-2024 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.