Allergan Recalls Combigan Eye Drops Due to Failed Impurity Specifications
Allergan is recalling 715,041 bottles of Combigan ophthalmic solution because the product failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or specification issues without reported harm.
Plain-English summary
Allergan Sales, LLC is recalling 715,041 bottles of COMBIGAN (brimonidine tartrate, timolol maleate) ophthalmic solution. The recall was initiated because the product failed impurities and degradation specifications.
The affected product is a prescription-only eye drop available in 2.5 mL, 5 mL, 10 mL, and 15 mL bottles. The specific lots involved are 94659, 94715, 94757, 94715A, 95297, 95223, and 95220, with expiration dates ranging from January 2019 to March 2019.
The product was distributed nationwide and in Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
- Brand
- COMBIGAN
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 715,041
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 (10)
- Lot #: a) 94659 Exp. FEB-2019
- b) 94715
- Exp. JAN-2019
- 94757
- Exp. FEB-2019
- 94715A
- 95297
- Exp. MAR-2019
- c) 95223 Exp. MAR-2019
- d) 95220 Exp. MAR-2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Allergan Sales, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · COMBIGAN
- ModerateAllergan Recalls 72 Bottles of Combigan Eye Drops for cGMP Deviations
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