Combigan 0 recalled over manufacturing violations

Recall date

March 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Allergan Sales, LLC recalls Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irv…

Recall number

D-1056-2019

FDA classification

Class II

Brand / firm

Allergan Sales, LLC

Sold / distributed

TN only

Why it was recalled

cGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05