Nano PNC Water recalled over sterility concerns
- Recall date
- December 13, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pacific Medical Solutions recalls Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
- Recall number
- D-0505-2017
- FDA classification
- Class I
- Brand / firm
- Pacific Medical Solutions
- Sold / distributed
- Nationwide in the United States and Mexico
Why it was recalled
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
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