ANI Pharmaceuticals recalls 500mg Pyrazinamide Tablets due to cGMP deviations. This affects Rx-only bottles manufactured by ULTRAtab Laboratories in Highland, NY. No specific remedy is listed in the recall notice.
cGMP Deviations
ANI Pharmaceuticals is recalling 500mg Pyrazinamide Tablets (100-count bottles) that were manufactured by ULTRAtab Laboratories. The recall is due to cGMP deviations, which means the product may not meet quality standards. This is a prescription-only medication.
cGMP deviations refer to failures in the manufacturing process that could affect product quality. This means the tablets might not be safe or effective for medical use. However, the recall does not specify the exact risk to patients.
Prescription patients who have the specific 500mg Pyrazinamide Tablets manufactured by ULTRAtab Laboratories in Highland, NY. Patients using this medication for tuberculosis treatment are most at risk.
Check for 500mg Pyrazinamide Tablets in 100-count bottles with the lot number 19B064A and expiration date 03/2022. These were distributed by Par Pharmaceuticals in Chestnut Ridge, NY.
Look for the lot number 19B064A and expiration date 03/2022 on the packaging.
The recall states there were cGMP deviations, but does not specify if the product is unsafe. Patients should consult their healthcare provider.
The recall does not provide a specific remedy. Patients should check with their healthcare provider for guidance.
Check for the lot number 19B064A and expiration date 03/2022 on the packaging.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0568-2022 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0568-2022 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.
