ANI Pharmaceuticals recalls 2mg Alprazolam tablets due to cGMP deviations in manufacturing. Products sold in 100-count and 500-count bottles with specific lot numbers and expiration dates.
cGMP Deviations
ANI Pharmaceuticals is recalling 2mg Alprazolam tablets that were manufactured with cGMP deviations. This means the tablets may not meet quality standards and could be unsafe for use.
cGMP deviations refer to failures in the manufacturing process that could affect the quality and safety of the medication. This might mean the tablets do not meet the required standards for effectiveness or safety.
Prescription holders of the 2mg Alprazolam tablets in 100-count or 500-count bottles with specific lot numbers and expiration dates. People taking these medications are most at risk.
Check for 100-count bottles (NDC 67253-903-10) or 500-count bottles (NDC 67253-903-50) with lot numbers 19C002A, 19E012A, 19E013A, 19C100B, 19E001B, or 19E002B.
Identify the product by checking the lot number and expiration date on the bottle.
The tablets were manufactured with cGMP deviations, which means they may not meet quality and safety standards.
Look for 100-count bottles (NDC 67253-903-10) or 500-count bottles (NDC 67253-903-50) with specific lot numbers and expiration dates.
The recall record does not specify a remedy, so contact your healthcare provider for advice.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0567-2022 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0567-2022 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.
