D-0505-2017 Class I Terminated
FDA drug recall D-0505-2017 was initiated by Pacific Medical Solutions on December 13, 2016 and is designated Class I. 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. The recall status is terminated (terminated March 28, 2017). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- December 13, 2016
- Termination Date
- March 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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 Pattern
Nationwide in the United States and Mexico
Code Information
None