Teva Pharmaceuticals USA recalls 4 mL Norepinephrine Bitartrate injections due to lack of sterility assurance. This could lead to infections if used improperly. Contact Teva for details.
Lack of Assurance of Sterility
Teva Pharmaceuticals USA is recalling 4 mL single-dose vials of Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL) because they lack sterility assurance. This means the product could cause infections if used, especially in medical settings where sterility is critical.
The product lacks assurance of sterility, meaning it could be contaminated with bacteria. If injected, this could lead to infections, particularly in medical settings where sterility is critical for patient safety.
Healthcare professionals and patients prescribed this medication. Those using the product without proper sterility checks are at higher risk of infection.
Check for the product name 'Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL)', 4 mL single-dose vials, 10 per carton, manufactured by Teva Pharmaceuticals USA. Lot # 100020800 with expiration 07/2022.
Verify the product name, lot number, and expiration date to confirm if it's part of the recall.
The recall indicates a lack of sterility assurance, so it should not be used until the remedy is confirmed.
The recall record does not specify a remedy or replacement process.
The expiration date is 07/2022 for lot # 100020800.
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0371-2022 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0371-2022 from Teva Pharmaceuticals USA. 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.
