The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1056-2019·Announced 2019-04-03

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.

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 2/5 (Moderate).

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:

Related recalls

Same brand · COMBIGAN

Same manufacturer · Allergan Sales, LLC

See all →

Same hazard · cGMP deviations

See all →

Similar recalls