Advanced Pharmaceutical Technology recalls TESTO-200 testosterone injection vials marketed without FDA approval. This product was sold with an unapproved NDA/ANDA, posing regulatory risks but not immediate safety hazards.
Marketed Without an Approved NDA/ANDA
Advanced Pharmaceutical Technology is recalling TESTO-200 testosterone injections because they were marketed without FDA approval. This means the product was not properly reviewed for safety and effectiveness before being sold, which could lead to regulatory issues but does not pose an immediate physical risk to users.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) from the FDA. This means it did not undergo the standard safety and efficacy reviews required for prescription drugs, potentially leading to unverified risks.
People who purchased TESTO-200 testosterone injections from authorized pharmacies or clinics. Those using the product for medical purposes are most at risk due to the lack of FDA approval.
Check for the product name 'TESTO-200', the NDC code 57377-200-01, and the lot number P-24-1. The product was sold with an expiration date of February 28, 2027.
Verify the product name, NDC code, and lot number to confirm if it matches the recalled items.
The recall is due to unapproved marketing, not immediate safety risks. However, the product was not reviewed by the FDA for safety and effectiveness.
The official recall does not specify a remedy, so check with your healthcare provider or pharmacy for guidance.
The recall is for regulatory reasons, not physical safety hazards. There is no mention of injury risks in the official notice.
We’ve drafted a message you can send Advanced Pharmaceutical Technology to request your refund or repair — edit it as you like.
Subject: Recall D-0531-2025 — Advanced Pharmaceutical Technology Advanced Pharmaceutical Technology Hello, I own a Advanced Pharmaceutical Technology that is covered by recall D-0531-2025 from Advanced Pharmaceutical Technology. 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.
