Lupin Pharmaceuticals recalls Gatifloxacin Ophthalmic Solution 0.5% 2.5mL bottles due to stability issues that could alter drug concentration. Rx only product manufactured in India with specific lot and expiration.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% 2.5 mL bottles because stability testing showed the solution may lose water and change drug concentration. This could affect the medication's effectiveness if used as directed.
The solution may lose water during storage, which could change the drug concentration and reduce effectiveness. This is a stability issue that might affect the medication's potency but does not pose an immediate safety risk.
Prescription eye drop users who have the specific 2.5 mL bottle with lot number H002512 expiring March 2022. Patients using this medication under a doctor's supervision are most at risk.
Check for the 2.5 mL bottle labeled 'Gatifloxacin Ophthalmic Solution 0.5%' with lot number H002512 and expiration date March 2022. This prescription-only eye drop was manufactured in India by Lupin Limited.
Verify the lot number and expiration date on the bottle to confirm if it matches the recalled batch.
The recall is due to potential stability issues that might affect drug concentration, but the product is not unsafe in normal use. It may not be as effective as intended.
The recall does not specify a remedy, so check the product details and contact your doctor if you have concerns about effectiveness.
Look for the 2.5 mL bottle with lot number H002512 and expiration date March 2022, manufactured by Lupin Limited in India.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0091-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0091-2022 from Lupin 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
