The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0585-2016·Announced 2016-01-27

Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure

Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, 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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The failure of the preservative test poses a risk of infection, which aligns with the 'Severe' criteria for significant injury potential without confirmed fatalities.

Plain-English summary

Mylan Pharmaceuticals, 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 2.5 mL and 5 mL bottles of the medication. The specific reason for the recall is that the product failed a preservative effectiveness test, which is required to ensure the solution remains sterile after the bottle is opened.

The affected products are identified by specific National Drug Codes (NDCs) and lot numbers. The 2.5 mL bottles (NDC 0378-7110-35) include lots AD4819, AC7894, AD2527, AC6330, and AC2330. The 5 mL bottles (NDC 00378-7109-35) include lots AD4515 and AC2328. The recall is distributed nationwide.

Patients who have been prescribed this medication should check their bottles for the affected lot numbers and expiration dates listed above. If the product matches the recalled lots, patients should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements.

The recalled product

Product
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Manufacturer
Mayne Pharma Usa
Category
Drug — Ophthalmic Solution
Hazard

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 (11)

  • a) Lot numbers: 0378-7110-35 AD4819
  • Exp. Date: 08-2016
  • 0378-7110-35 AC7894
  • Exp. Date: 05-2016
  • 0378-7110-35 AD2527
  • Exp. Date: 06-2016
  • 0378-7110-35 AC6330
  • 0378-7110-35 AC2330
  • Exp. Date: 04-2016 and b) Lot numbers: 0378-7109-35 AD4515
  • Exp. Date: 04-2016 and 0378-7109-35 AC2328
  • Exp. Date: 01-2016.

Distribution

Distributed nationwide across the United States.

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