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Recall Observatory FDA recall evidence

Drug product

Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy

D-0296-2017

November 17, 2016

Class II

Product summary

Firm
Tri-Coast Pharmacy
Event
Event 75763
Status
Ongoing
Classification
Class II
Quantity
90 vials
Official record key
drug-enforcement:D-0296-2017

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): 06282016C (12/25/2016), 10242016A (10/27/2016), 10212016A (10/24/2016).

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility