ANI Pharmaceuticals recalls 0.25mg alprazolam tablets from specific bottle counts and lots due to cGMP deviations. These prescription-only medications may not meet quality standards.
cGMP Deviations
ANI Pharmaceuticals is recalling 0.25mg alprazolam tablets in 100-count, 500-count, and 1000-count bottles with specific lot numbers because of manufacturing quality issues. This recall affects prescription-only medications that may not meet safety standards.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the tablets may not meet the required quality standards for safety and effectiveness. This could potentially affect the medication's performance but does not indicate immediate danger to users.
Prescription holders of the recalled alprazolam tablets. People taking these medications for anxiety or related conditions are most at risk if they use the affected lots.
Check for 100-count, 500-count, or 1000-count bottles with NDC codes 67253-900-10, 67253-900-50, or 67253-900-11. The lot numbers include 19C003A (exp. 03/2022), 19G002A (exp. 07/2022), 19C004B (exp. 03/2022), and 19C048C (exp. 03/2022).
Identify the NDC code and lot number on the bottle to confirm if it's part of the recalled batch.
ANI Pharmaceuticals is recalling these alprazolam tablets due to cGMP deviations, which means the manufacturing process did not meet quality standards.
The official recall notice does not specify a remedy or action for affected products.
The recall is for quality issues, not immediate safety risks. The medication may not meet quality standards but does not indicate a risk of serious injury.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0564-2022 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0564-2022 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.
