FDA recall D-0429-2019

Product

Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.

Reason for recall

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

Distribution

Nationwide within the United States.

Key facts

Status

Terminated

Initiation date

2019-01-28

Report date

2019-02-13

Termination date

2020-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2019