ANI Pharmaceuticals recalls 0.5mg Alprazolam tablets with specific NDC codes and expiration dates due to cGMP deviations. Affected products may not meet quality standards.
cGMP Deviations
ANI Pharmaceuticals is recalling 0.5mg Alprazolam tablets in specific bottle counts and lot numbers because of manufacturing deviations. This could affect product quality and safety.
The recall is due to cGMP deviations, which are manufacturing quality control issues. These deviations could lead to products not meeting safety and quality standards, but the specific risk to users is not clearly described in the notice.
People who have the recalled Alprazolam tablets with the listed NDC codes and expiration dates are affected. Those using prescription medication for anxiety or related conditions are most at risk.
Check the product label for the NDC codes 67253-901-10, 67253-901-50, or 67253-901-11 and expiration dates listed in the recall notice. The tablets are prescription-only and distributed by Par Pharmaceutical.
Look for the NDC codes 67253-901-10, 67253-901-50, or 67253-901-11 and expiration dates matching the recall list.
The recall is due to cGMP deviations, which are manufacturing quality control issues that may affect product safety and quality.
The official notice does not specify a remedy or action for affected products.
Yes, the recall includes specific lot numbers with expiration dates listed in the notice.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0565-2022 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0565-2022 from ANI 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.
