FDA-Drug2020-01-08Class III

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.

Lupin Pharmaceuticals Inc.
Hazard

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

Sold states
Nationwide in the U.S.
Affected count
2,130 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0635-2020

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