Cipla recalls 0.05% Difluprednate Ophthalmic Emulsion bottles due to potential sterility issues from protective cap breakage. Affected lots expire 01/2023 to 07/2023.
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Cipla is recalling certain eye drop bottles that may have broken protective caps, risking contamination of the medication. This could lead to infections if the drops are used without proper sterility.
The protective cap on the bottle can break, exposing the eye drop tip. This may allow contamination, increasing infection risk if the drops are used without sterility.
People with prescriptions for Difluprednate Ophthalmic Emulsion 0.05% 5mL bottles from Cipla USA. Those using the product without proper eye drop handling are most at risk.
Check for Cipla USA manufactured 5mL eye drop bottles with lot numbers DEG1HC2 through DEG3BD2. These bottles expire between January 2023 and July 2023.
Look for lot numbers DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2 (expiring 01/2023), DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2 (expiring 02/2023), or DEG1LC2, DEG2LC2 (expiring 05/2023), or DEG1BD2, DEG2BD2, DEG3BD2 (expiring 07/2023).
Talk to your healthcare provider about whether you have the recalled product and if you need to switch to a different treatment.
The recall is due to potential contamination risk from broken protective caps. If the cap is intact, the product may be safe, but you should check the lot number and contact your doctor.
Check for Cipla USA manufactured 5mL bottles with lot numbers DEG1HC2 through DEG3BD2, which expire between January 2023 and July 2023.
Contact your doctor to discuss whether you need to stop using the product or switch to a different treatment.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-1499-2022 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-1499-2022 from Cipla. 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.
