Skip to content
Recall Observatory FDA recall evidence

Drug product

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.

D-0684-2017

April 06, 2017

Class II

Product summary

Firm
Isomeric Pharmacy Solution, LLC
Event
Event 76951
Status
Terminated
Classification
Class II
Quantity
1,951 vials
Official record key
drug-enforcement:D-0684-2017

Official wording

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

Code information: Lot #s: 10013, Exp 05/10/17; 10020, Exp 05/20/17; 10029, Exp 05/27/17; 11002, Exp 05/30/17; 11013, Exp 06/04/17.

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility