Teva Pharmaceuticals recalls Azacitidine 100mg/vial lyophilized powder (Rx only) manufactured in Romania due to subpotent drug results from stability testing. This may affect medication effectiveness.
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Teva Pharmaceuticals is recalling Azac:itidine for Injection 100mg/vial lyophilized powder (Rx only) because stability testing showed the drug is less potent than expected. This could mean the medication isn't as effective as it should be for patients needing it.
The drug testing showed results below the required potency level. This means the medication might not work as effectively as it should for patients who need it. However, this does not cause immediate harm or injury.
Patients prescribed this medication by a doctor are affected. Those using the product without a prescription are not impacted since it's Rx only.
Check for the product name 'Azacitidine for Injection 100mg/vial Lyophilized Powder', Rx only, manufactured in Romania by Sindan Pharma SRL for BluePoint Laboratories. The NDC code is 68001-313-56 and lot number FE22001A (expires 01/2024).
Verify the product name, NDC code, and lot number to confirm if it's recalled.
The recall is due to potential reduced effectiveness, not immediate safety risks. It is safe to use if the medication is still within its expiration date and prescribed by a doctor.
The recall does not require immediate action. Check the product details and contact your doctor if you have concerns about effectiveness.
No, the hazard is related to reduced medication effectiveness, not physical injury or harm.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1334-2022 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-1334-2022 from Teva 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.
