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Recall Observatory FDA recall evidence

Drug product

Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

D-403-2014

October 18, 2013

Class II

Product summary

Firm
Compounding Centre At Blue Ridge
Event
Event 66568
Status
Terminated
Classification
Class II
Quantity
3 Vials
Official record key
drug-enforcement:D-403-2014

Official wording

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Code information: All Lots

Distribution pattern: NC

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility