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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

D-0299-2017

November 17, 2016

Class II

Product summary

Firm
Tri-Coast Pharmacy
Event
Event 75763
Status
Ongoing
Classification
Class II
Quantity
2,818 vials
Official record key
drug-enforcement:D-0299-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016D (11/19/2016), 06162016A (12/13/2016), 06132016A (12/10/2016), 07282016I (01/24/2017), 08172016D (02/13/2017), 08042016C (01/31/2017), 09222016F (03/21/2017), 09062016A (02/28/2017), 10272016B (02/28/2017), 10252016D (02/28/2017), 08252016B (02/21/2017), 11022016C (05/01/2017).

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility