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Recall Observatory FDA recall evidence

Drug product

CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

D-1156-2018

August 21, 2018

Class II

Product summary

Firm
Auro Pharmacies, Inc.
Event
Event 80890
Status
Terminated
Classification
Class II
Quantity
39 vials
Official record key
drug-enforcement:D-1156-2018

Official wording

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Code information: Lot #: 180626/3, Exp 25-Aug-18

Distribution pattern: Nationwide in USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility