The Recall Desk
CriticalFDA (Drugs)·D-0505-2017·Announced 2017-03-08

Pacific Medical Solutions Recalls Nano PNC Water Due to Bacterial Contamination

Pacific Medical Solutions is recalling Nano PNC Water because it was marketed without FDA approval and tested positive for the bacterium variovorax paradoxus.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.

Plain-English summary

Pacific Medical Solutions is recalling Nano PNC Water, a prescription-only product packaged in amber glass bottles and associated with the Immune Cellular Restoration Program. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and was found to be non-sterile.

Samples of the product, which is administered via nebulizer, were tested and found to contain the bacterium variovorax paradoxus. The product was distributed nationwide in the United States and in Mexico.

Consumers who have purchased or received this product should stop using it immediately and contact their healthcare provider or the recalling firm for further instructions on disposal or return.

The recalled product

Product
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Manufacturer
Pacific Medical Solutions
Category
Drug — Prescription Drug
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • None

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · bacterial contamination

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