Difluprednate Eye Drops Recalled for Defective Container Sterility Risk
Cipla is recalling 117,844 bottles of Difluprednate eye drops nationwide due to defective containers where the protective cap can break, potentially exposing the dropper tip and compromising sterility.
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 for a defective ophthalmic container that could compromise product sterility, qualifying as a risk-of-harm product. No illnesses, injuries, or hospitalizations have been reported, making the hazard theoretical rather than established.
Plain-English summary
Cipla USA, Inc. is recalling Difluprednate Ophthalmic Emulsion 0.05% in 5 mL bottles. Approximately 117,844 bottles have been distributed nationwide in the United States.
The recall was initiated because of a defective container where the protective cap can break, exposing the dropper tip. This exposure could compromise the sterility of the product.
Consumers who have received the affected product should stop using it and consult their healthcare provider for a replacement. The affected lot numbers are: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2 (expiration 01/2023), DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2 (expiration 02/2023), DEG1LC2, DEG2LC2 (expiration 05/2023), and DEG1BD2, DEG2BD2, DEG3BD2 (expiration 07/2023).
The recalled product
- Product
- DIFLUPREDNATE (DIFLUPREDNATE)
- Brand
- DIFLUPREDNATE
- Manufacturer
- CIPLA
- Category
- Drug — Ophthalmic
- Hazard
- sterility-compromise
- defective-container
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 (19)
- Lot #: DEG1HC2
- DEG2HC2
- DEG3HC2
- DEG4HC2
- DEG5HC2
- DEG6HC2
- Exp 01/2023
- DEG1IC2
- DEG2IC2
- DEG3IC2
- DEG4IC2
- Exp 02/2023
- DEG1LC2
- DEG2LC2
- Exp 05/2023
- DEG1BD2
- DEG2BD2
- DEG3BD2
- Exp 07/2023
Distribution
Distributed nationwide across the United States.
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