Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restorat...
FDA Recall #D-0505-2017 — Class I — December 13, 2016
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.
Recalling Firm
Pacific Medical Solutions — Jamul, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the United States and Mexico
Code Information
None
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated