Allergan Recalls 72 Bottles of Combigan Eye Drops for cGMP Deviations
Allergan is voluntarily recalling 72 bottles of Combigan ophthalmic solution in Tennessee due to current Good Manufacturing Practice (cGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to cGMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/quality errors without reported serious injuries.
Plain-English summary
Allergan Sales, LLC is voluntarily recalling 72 bottles of Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles. The recall was initiated on March 19, 2019, and was reported to the FDA on April 3, 2019. The specific lot affected is Lot #99946, with an expiration date of January 16, 2021.
The reason for the recall is cited as current Good Manufacturing Practice (cGMP) deviations. The FDA classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed only in Tennessee (TN). Consumers who have this specific lot of Combigan should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall was terminated on April 29, 2020.
The recalled product
- Product
- COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
- Brand
- COMBIGAN
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 72
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#: 99946 Exp. January 16
- 2021
Distribution
Distributed in 1 state:
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