Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

Recall Number: D-0635-2020

Firm: Lupin Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20200108

Initiation Date: 20191213

Termination Date: 20201019

Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.