Apotex Recalls Bromfenac Ophthalmic Solution Due to Sterility Concerns
Apotex Inc. is recalling specific lots 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. According to the rubric, FDA Class II recalls with potential for significant injury or structural defects (like sterility failure in eye drops) are rated as Severe (4).
Plain-English summary
Apotex Inc. is recalling specific lots of Bromfenac Ophthalmic Solution 0.09%, a prescription eye drop, due to a lack of assurance of sterility. The recall involves 1.7 mL and 2.5 mL bottles manufactured for Apotex Corp. The affected lots are MF0537, MF8090, and MF0532, all with an expiration date of 07/2016. The total quantity recalled is 38,802 bottles.
The recall was initiated because the product failed preservative effectiveness testing. This failure means the FDA cannot guarantee that the product remains sterile after the bottle is opened, which is a critical safety requirement for ophthalmic solutions. The agency has classified this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if they are currently using this medication.
The recalled product
- Product
- Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
- Manufacturer
- Apotex Inc.
- Category
- Drug — Ophthalmic Solution
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 (4)
- Lot #: a) MF0537
- Exp 07/2016
- b) MF8090
- MF0532
Distribution
Distributed nationwide across the United States.
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