Newark, NJ, United States
Pharmaceutical Innovations, Inc. recalls
2 recalls recorded since 2018, most recently on 13 August 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 August 2020
- Terminated
- 16 September 2021
- Reason
- The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
- Distribution
- US Nationwide distribution including in the state of Nevada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2830-2020
- Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient
Terminated Class II Medical devices
- Recall started
- 19 June 2019
- Terminated
- 29 July 2020
- Reason
- Potential for failed stability antimicrobial effectiveness testing.
- Distribution
- US nationwide distribution including the states of AZ, CA, CT, FL, IL, MA, MI, MN, NC, NJ, NY, OH, PA, RI, TX, TN, VT, WV. Distributed Internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1969-2019, Z-1972-2019, Z-1970-2019, Z-1971-2019, Z-1968-2019
- ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
- Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
- ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
- ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
- Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.