Lupin Pharmaceuticals recalls Gatifloxacin Ophthalmic Solution 0.5% 2.5mL bottles due to stability issues that could alter drug concentration. This Rx-only medication was manufactured in India with specific lot numbers and expiration dates.
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% 2.5mL bottles because stability testing showed the solution may lose water and change drug concentration. This could affect the medication's effectiveness for eye treatments.
The solution may lose water during storage, which could change the drug concentration. This might make the medication less effective for treating eye infections or inflammation. The issue was found through stability testing that showed out-of-specification results.
Prescription eye drop users who have the specific 2.5mL bottles with lot numbers H003037 (exp. May 2022), H100132 (exp. June 2022), or H100847 (exp. October 2022). Patients using this medication for eye conditions are most at risk.
Check for the 2.5mL bottle labeled 'Gatifloxacin Ophthalmic Solution 0.5%'. Look for lot numbers H003037 (expires May 2022), H100132 (expires June 2022), or H100847 (expires October 2022).
Look for the lot numbers H003037, H100132, or H100847 on the bottle label to confirm if your product is affected.
The recall is due to stability issues that might affect drug concentration, but the medication is still safe to use if stored properly. The manufacturer recommends checking the lot numbers.
Check for the 2.5mL bottle with lot numbers H003037 (expires May 2022), H100132 (expires June 2022), or H100847 (expires October 2022).
The recall does not specify a remedy, so you should check with your doctor or pharmacist about whether to continue using the medication.
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0326-2022 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0326-2022 from Lupin. 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.
