January 09, 2020
Lupin Pharmaceuticals Inc. has initiated a voluntary recall for 2130 bottles of bimatoprost ophthalmic solution 0.03% because samples were out-of-specification for impurities during routine testing. The recall was included in the January 8, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 7.5-mL bottles of bimatoprost (NDC 68180-429-03) from lot H801686 (Exp. 12/31/19). The bottles were distributed nationwide.
Lupin Pharmaceuticals initiated the voluntary recall December 13, 2019. On January 2, 2020, the FDA designated the recall Class III, suggesting use of the affected solution is unlikely to cause adverse health consequences.
Bimatoprost ophthalmic solution is available with a prescription to reduce pressure inside the eye from glaucoma.