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Recall Observatory FDA recall evidence

Drug product

Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.

D-0683-2017

April 06, 2017

Class II

Product summary

Firm
Isomeric Pharmacy Solution, LLC
Event
Event 76951
Status
Terminated
Classification
Class II
Quantity
2,335 vials
Official record key
drug-enforcement:D-0683-2017

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: 09032, Exp 04/06/17; 10017, Exp 04/19/17; 10022, Exp 04/26/17; 10031, Exp 05/04/17; 11021, Exp 05/17/17; 12007, Exp 06/16/17.

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