Difluprednate eye drops recalled for defective container closure affecting sterility
Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product—a sterile ophthalmic medication with defective container closure compromising sterility assurance. No illnesses, injuries, hospitalizations, or deaths have been reported, placing it below Severe but above Moderate due to the inherent risk of infection from unsterile eye medications.
Plain-English summary
Cipla USA, Inc. has issued a nationwide recall of Difluprednate ophthalmic emulsion 0.05% due to defective container closures. The recall affects lot DEG3LC2 (expiration 05/2023), comprising approximately 7,992 bottles distributed throughout the United States.
The defective container closure prevents assurance that the product maintains its required sterility. For ophthalmic medications, sterility is critical to prevent eye infections and other serious complications.
Patients currently using the affected product should discontinue use immediately and contact their prescribing healthcare provider. Healthcare providers treating patients with this medication should verify whether their patients received product from the affected lot and inform them of the recall. The product should not be used.
The recalled product
- Product
- DIFLUPREDNATE (DIFLUPREDNATE)
- Brand
- DIFLUPREDNATE
- Manufacturer
- CIPLA
- Category
- Drug — Ophthalmic
- Affected units
- 7,992
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # DEG3LC2
- Exp 05/2023
Distribution
Distributed nationwide across the United States.
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