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.
Product description
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Lot numbers, UPCs & expiration codes
None
Where it was sold
Nationwide in the United States and Mexico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0505-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 13, 2016
- FDA report date
- Mar 8, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pacific Medical Solutions
Original FDA data
Every field from FDA enforcement report D-0505-2017, exactly as published.
Show all FDA fields
- City
- Jamul
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 76109
- Address
- 13967 Campo Rd Ste 102
- Code information
- None
- Postal code
- 91935-3232
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0505-2017
- Classification
- Class I
- Recalling firm
- Pacific Medical Solutions
- Termination date
- Mar 28, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
- Distribution pattern
- Nationwide in the United States and Mexico
- Recall initiation date
- Dec 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2017