FDA recall D-0687-2017

Product

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.

Reason for recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-04-06

Report date

2017-05-03

Termination date

2017-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0687-2017