D-0199-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2023
- Initiation Date
- December 22, 2022
- Termination Date
- July 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, 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@41