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Recall Observatory FDA recall evidence

Drug product

Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.

D-0505-2017

December 13, 2016

Class I

Product summary

Firm
Pacific Medical Solutions
Event
Event 76109
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0505-2017

Official wording

Reason: Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.

Code information: None

Distribution pattern: Nationwide in the United States and Mexico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.