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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.

D-0686-2017

April 06, 2017

Class II

Product summary

Firm
Isomeric Pharmacy Solution, LLC
Event
Event 76951
Status
Terminated
Classification
Class II
Quantity
2,156 vials
Official record key
drug-enforcement:D-0686-2017

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: 09018, Exp 04/17/17; 09023, Exp 04/22/17; 09024, Exp 04/23/17; 09027, Exp 04/25/17; 09031, Exp 04/30/17; 10005, Exp 05/06/17; 10010, Exp 05/09/17; 11022, Exp 06/10/17; 11038, Exp 06/18/17; 11044, Exp 07/04/17; 12003, Exp 07/08/17; 12010, Exp 07/12/17; 12021, Exp 07/30/17.

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