Riboflavin 5-Phosphate Sodium Ophthalmic Solution recalled over sterility concerns

Recall date

June 18, 2019

Source

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

Official notice title

Premier Pharmacy Labs Inc recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Phar…

Recall number

D-1425-2019

FDA classification

Class II

Brand / firm

Premier Pharmacy Labs Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.