Difluprednate Eye Drops Recalled for Defective Container Compromising Sterility
CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion nationwide due to defective protective caps that could expose the dropper tip and compromise sterility. No injuries have been reported.
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 is an FDA Class II recall involving a defective medical container that poses a risk of sterility compromise and potential eye infection. No illnesses or injuries have been reported, meeting the rubric criterion for a score of 3 (risk-of-harm product where injury has not yet been reported).
Plain-English summary
CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion, 0.05%, nationwide due to a manufacturing defect in the protective cap.
The issue stems from defective containers where the protective cap can break or fail to properly seal. This exposes the dropper tip, which could allow contamination and compromise the sterility of the eye drops.
Affected lot is DEG5BD2 with expiration date 07/2023. The product is distributed nationwide across the U.S. in 5 mL bottles marked for prescription use only.
Consumers should stop using affected bottles immediately and contact their healthcare provider or pharmacist. Those with affected lot numbers should return the product to their pharmacy.
The recalled product
- Product
- Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
- Manufacturer
- CIPLA
- Affected units
- 3,468
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 # DEG5BD2
- Exp 07/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by CIPLA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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