FDA Recall D-0505-2017
Pacific Medical Solutions · Jamul, CA
Class I — life-threatening Terminated 105 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0505-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the United States and Mexico
- Recall initiated
- 2016-12-13
- Classified by FDA Center
- 2017-03-01
- FDA published
- 2017-03-08
- Terminated
- 2017-03-28
- Recalling firm
- Pacific Medical Solutions
- Firm location
- Jamul, CA