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Recall Observatory FDA recall evidence

Drug product

LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

D-0565-2017

February 10, 2017

Class II

Product summary

Firm
Synergy Rx
Event
Event 76472
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0565-2017

Official wording

Reason: Lack of Assurance of Sterility: There are also CGMP Deviations.

Code information: All Lots

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility