Eye Drops Recalled

Lupin Pharmaceuticals Inc. is recalling nearly 675,000 bottles of moxifloxacin ophthalmic solution 0.5% (NDC 68180-422-01). According to the March 6, 2019, US Food and Drug Administration (FDA) Enforcement Report, the recall is an expansion of earlier recalls, which were prompted by out-of-specification results for impurities during routine product testing. 

The recall affects 3-mL bottles from the following lots: H701618, H701619, and H701620 (Exp. 3/19); H702220, H702221, H702222, H702223, H702224, H702225, and H702351 (Exp. 4/19); H702971, H702972, H702973, H702974, H703151, H703152, and H703153 (Exp. 6/19); H703155, H703682, and H703683 (Exp. 7/19); H704243, H704245, and H704247 (Exp. 9/19); H704707, H704709, H705038, and H705039 (Exp. 10/19); H705561 (Exp. 11/19); H800394, H800395, H800617, and H800618 (Exp. 1/20); H801585, H801586, H801721, and H801722 (Exp. 3/20); H802138, H802139, and H802140 (Exp. 4/20); H802421, H802707, and H802718 (Exp. 5/20); H803187, H803188, and H803232 (Exp. 6/20); H803749 and H803750 (Exp. 7/20); H804326, H804327, H804328, H804330, H804549, H804552, H804630, and H804632 (Exp. 9/20); H805163, H805361, H805362, and H805676 (Exp. 11/20); and H805690, H805692, and H805694 (Exp. 11/20). 

The bottles were distributed throughout the United States and in Puerto Rico.

Lupin Pharmaceuticals voluntarily initiated the recall February 26, 2019. On February 28, 2019, the FDA designated the recall Class III, which communicates use of the affected capsules is unlikely to cause adverse health consequences.

Moxifloxacin ophthalmic solution is a prescription antibiotic used to treat bacterial conjunctivitis. 

—Jolynn Tumolo