FDA recall D-0505-2017

Pacific Medical Solutions · Class I · drug

Product

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.

Distribution

Nationwide in the United States and Mexico

Key facts

Status
Terminated
Initiation date
2016-12-13
Report date
2017-03-08
Termination date
2017-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jamul, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0505-2017