Class I
Terminated
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
This recall has been terminated (originally issued March 8, 2017).
- Company
- Pacific Medical Solutions
- Recall Initiated
- December 13, 2016
- Posted
- March 8, 2017
- Recall Number
- D-0505-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Jamul, CA, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
None
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