FDA-Drug2019-02-13Class III
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.
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Sold states
Nationwide within the United States.
Affected count
9,930 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2019Don't want to check this manually?
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