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.
Reported: May 3, 2017 Initiated: April 6, 2017 #D-0687-2017
Product Description
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.
Details
- Recalling Firm
- Isomeric Pharmacy Solution, LLC
- Units Affected
- 5,165 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 5,165 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 3, 2017. Severity: Moderate. Recall number: D-0687-2017.
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