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Recall Observatory FDA recall evidence

Drug product

Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy

D-0278-2017

November 17, 2016

Class II

Product summary

Firm
Tri-Coast Pharmacy
Event
Event 75763
Status
Ongoing
Classification
Class II
Quantity
701 vials
Official record key
drug-enforcement:D-0278-2017

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): 07112016A (12/31/2016), 08172016B (2/13/2017), 09122016C (02/28/2017), 10252016E (02/28/2017).

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility