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Recall Observatory FDA recall evidence

Drug product

TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.

D-0741-2022

March 14, 2022

Class II

Product summary

Firm
Vitae Enim Vitae Scientific, Inc.
Event
Event 89803
Status
Terminated
Classification
Class II
Quantity
722 boxes
Official record key
drug-enforcement:D-0741-2022

Official wording

Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information: Lot #: 21VTHI017, 21VTHI018, 21VTHI019, Exp 5/31/2023

Distribution pattern: Nationwide in the U.S.A

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    deviations from Current Good Manufacturing Practices
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility