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Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.
Promise Pharmacy announced on Oct. 22, 2018 that it was voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials to the consumer level. The recall is in response to unidentified small particulates that were found floating in the solution. The affected lot number is 09042018@2 with an expiration of 12/03/2018 and was distributed nationwide.
The product is used as a post-surgical (cataract) ophthalmic treatment. While the company has not received reports of adverse events, it says that use of contaminated product could result in limited eye irritation, inflammation, visual impairment, or permanent ocular damage.
The company stated in a press release that patients should stop using the product and return it to the company. Adverse events may be reported to FDA through its MedWatch program.