Bausch & Lomb Recalls Bromfenac Ophthalmic Solution Due to Sterility Concerns
Bausch & Lomb is recalling 13,995 bottles of Bromfenac Ophthalmic Solution, 0.09%, because preservative testing failed, raising concerns about 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an ophthalmic product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for adverse health consequences).
Plain-English summary
Bausch & Lomb, Inc. is recalling 13,995 bottles of Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL, prescription only. The recall is due to a lack of assurance of sterility caused by failed preservative effectiveness testing. The affected product is identified by Lot #221211 with an expiry date of 09/30/2015.
The product was distributed nationwide in the United States and in Puerto Rico. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
- Manufacturer
- Bausch & Lomb, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 13,995
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 #221211
- Expiry: 09/30/2015
Distribution
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