Glaucoma Drug Recalled

Lupin Pharmaceuticals Inc. is recalling 9930 bottles of bimatoprost ophthalmic solution 0.03% after tested samples failed to meet impurity specifications, according to the February 13, 2019, US Food and Drug Administration (FDA) Enforcement Report.

Recalled are 5-mL bottles (NDC 68180-429-02) from lots H804506 (Exp. 6/20), 803555 (Exp. 4/20), H805394 (Exp. 8/20) and 7.5-mL bottles f(NDC 68180-429-03) bottles from lots H804112 (Exp. 5/20) and H803220 (Exp. 3/20). The bottles were distributed throughout the United States. 

Lupin Pharmaceuticals voluntarily initiated the recall January 28, 2019. On February 5, 2019, the FDA designated it Class III. Under the recall classification, use of the affected solution is not likely to cause harm.

Bimatoprost ophthalmic solution is available with a prescription to reduce pressure inside the eye from glaucoma.  

—Jolynn Tumolo