BromSite Ophthalmic Solution Recalled for Lack of Sterility Assurance
Sun Pharmaceutical is recalling BromSite (bromfenac) 0.075% ophthalmic solution due to a lack of sterility assurance. The recall affects 69,840 bottles distributed nationwide.
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: The recall involves a risk-of-harm product (lack of sterility assurance in an ophthalmic solution) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical risks without confirmed illness.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 69,840 bottles of BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles. The product is a prescription-only ophthalmic solution distributed nationwide within the United States. The specific lot number is V18E01 with an expiration date of 05/2020.
The recall was initiated because the product may have a lack of sterility assurance. Sterility is critical for ophthalmic solutions to prevent infection. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discontinued and returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatments if necessary.
The recalled product
- Product
- BROMSITE (BROMFENAC)
- Brand
- BROMSITE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 69,840
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 #: V18E01
- Exp. 05/2020
Distribution
Distributed nationwide across the United States.
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