PlainRecalls
FDA Drug Moderate Class II Terminated

Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.

Reported: May 3, 2017 Initiated: April 6, 2017 #D-0684-2017

Product Description

Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.

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

Units Affected
1,951 vials
Distribution
Nationwide in the USA and Puerto Rico
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 1,951 vials.
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-0684-2017.