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Discoloration Prompts Recall of Pink Eye Drug


January 24, 2020

Customer reports of discoloration have prompted AuroMedics Pharma to pull more than 100,000 bottles of moxifloxacin ophthalmic solution, according to the January 22, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall includes moxifloxacin ophthalmic solution 0.5%, 3-mL bottles (NDC 65862-840-03) from lots CMF190008 (Exp. 4/21), CMF190009 (Exp. 4/21), CMF190025 (Exp. 6/21), and CMF190026 (Exp. 6/21). The bottles were distributed throughout the United States by Aurobindo Pharma USA. 

AuroMedics Pharma voluntarily initiated the recall December 2, 2019. The FDA designated the recall Class III on January 17, 2020. Under the recall classification, use of the affected solution is not likely to cause harm.

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

Jolynn Tumolo

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