SCA Pharmaceuticals recalls phenylephrine HCl 800 mcg/10mL injection with potential lack of sterility. Affected lots expire April 2024. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility
SCA Pharmaceuticals is recalling phenylephrine HCl injections that may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with expiration dates through April 2024.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. If injected, this could cause serious infections or other health complications.
Patients prescribed this medication by a healthcare provider. Those using the product without medical supervision are not affected as it is a prescription-only item.
Check the product label for the NDC code 70004-0816-12-K. Look for specific lot numbers: 1223048610, 1223048611, 1223048726, or 1223050163. The expiration dates range from April 10, 2024 to June 12, 2024.
Look for the NDC code 70004-0816-12-K and specific lot numbers listed in the recall notice.
The recall states there is a lack of assurance of sterility, so it is not safe to use as it could cause infections.
Contact SCA Pharmaceuticals directly for instructions on what to do with the product.
Check the product label for the NDC code 70004-0816-12-K and lot numbers: 1223048610, 1223048611, 1223048726, or 1223050163.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0421-2024 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0421-2024 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.
