D-0200-2023 Class II Terminated
FDA drug recall D-0200-2023 was initiated by Pharmacy Innovations on Dec 22, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. The recall status is terminated (terminated Jul 31, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 1, 2023
- Initiation Date
- Dec 22, 2022
- Termination Date
- Jul 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Distribution Pattern
Nationwide in the USA
Code Information
t20221109@43 t20221108@27 t20221011@41 t20221024@3 t20221104@37 t20221025@32 t20221025@33 t20221013@15 t20221017@5
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0200-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026