Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor…

Recall date

July 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1050-2018

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Product was distributed throughout the United States

Why it was recalled

Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01