December 2016 FDA Recall Drug by Pacific Medical Solutions
D-0505-2017 - Marketed without an Approved NDA/ANDA and non-sterility
This Class I drug recall was voluntarily initiated by Pacific Medical Solutions on December 13, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda and non-sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0505-2017
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
12-13-2016
03-08-2017
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pacific Medical Solutions
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States and Mexico
03-28-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Batch or Lot Expiration Information
Lot# None
