FDA Recalls Cipla Difluprednate Eye Drops for Defective Container Caps
Cipla is recalling 8,136 bottles of Difluprednate ophthalmic emulsion nationwide due to defective container caps that can break and expose the medication tip, compromising sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall involves a sterility-assurance defect on an ophthalmic medication where a defective cap can expose the product tip. Although no illnesses or injuries have been reported, compromised sterility on eye medications presents inherent risk of infection and complications.
Plain-English summary
Cipla USA, Inc. is recalling Difluprednate Ophthalmic Emulsion 0.05% due to defective container caps that can break during use or handling. When the protective cap fails, it exposes the tip of the eye dropper, which compromises the sterility of the medication. Batch DEG4LC2 with expiration date 05/2023 is affected.
The affected product was distributed nationwide in the United States. A total of 8,136 bottles are included in this recall. The defect was identified based on customer complaints regarding breakage of the protective cap.
Patients using this medication should stop using bottles from batch DEG4LC2 immediately. If you have a bottle bearing this batch number, do not instill it into your eyes. Contact your pharmacy or healthcare provider for a replacement or alternative medication. If you have questions or believe you have been affected, consult your healthcare provider or pharmacist.
The recalled product
- Product
- DIFLUPREDNATE (DIFLUPREDNATE)
- Brand
- DIFLUPREDNATE
- Manufacturer
- CIPLA
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 8,136
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)
- Batch# DEG4LC2
- exp. date 05/2023
Distribution
Distributed nationwide across the United States.
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