Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles,
Recalled February 13, 2019 · FDA recall D-0429-2019 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities. · FDA Class III
Units
9,930 bottles
Sold at
Nationwide within the United States.
Description
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
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.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →