FDA-Drug2019-07-03Class II
Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
Premier Pharmacy Labs Inc
Hazard
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Sold states
Nationwide in the USA
Affected count
125 dropper bottles
Manufactured in
8265 Commercial Way, N/A, Weeki Wachee, FL, United States
Products
Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1425-2019Don't want to check this manually?
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