PlainRecalls
CriticalClass ITerminated

FDA Drug recall · Reported March 8, 2017

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

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

Recall #
D-0505-2017
Affected scope
N/A
Initiated
December 13, 2016
Verify with FDA Drug →
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Pacific Medical Solutions recalled Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular … — a critical-severity action.

Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular … was recalled by Pacific Medical Solutions in March 8, 2017. Reason: Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found t…. Check the official notice for the remedy. Verify recall #D-0505-2017 with the FDA Drug before acting.

The recall

Pacific Medical Solutions issued this critical-severity FDA Drug recall — Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found t….

Critical
severity level
Class I
classification
March 8, 2017
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0505-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0505-2017) was formally reported on March 8, 2017, with the manufacturer initiating the action on December 13, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Pacific Medical Solutions is listed as the recalling firm, operating out of Jamul, CA. Federal records list the affected scope as N/A.

The documented reason for this recall is: Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus. Distribution data in the federal record shows the product reached: Nationwide in the United States and Mexico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category — 3,146 children & baby products recalls on record

0100200300400500 20052008201120142017202020232026 128

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Critical

Affected scope

N/A

Related Recalls

6

0 from same agency

Product description

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

Reason for recall

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-0505-2017
Date reported March 8, 2017
Date initiated December 13, 2016
Recalling firm Pacific Medical Solutions
Firm location Jamul, CA
Affected scope N/A
Distribution Nationwide in the United States and Mexico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0505-2017) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting — recall details can be updated.
  • This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.. Recalled by Pacific Medical Solutions. Units affected: N/A.
Why was this product recalled?
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Critical. Recall number: D-0505-2017.
Where was the recalled product distributed?
Distribution: Nationwide in the United States and Mexico.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0505-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle →

Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported March 8, 2017.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.