FDA recall D-0635-2020

Product

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.

Reason for recall

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

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-12-13

Report date

2020-01-08

Termination date

2020-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

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