FDA-Drug2017-05-03Class II
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
Isomeric Pharmacy Solution, LLC
Hazard
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
5,165 bottles
Manufactured in
2401 S Foothill Dr Ste D, N/A, Salt Lake City, UT, United States
Products
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0687-2017Don't want to check this manually?
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