D-0191-2023 Class II Terminated
FDA drug recall D-0191-2023 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
Acetylcysteine 10% Ophthalmic 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
t20221011@36 t20221108@24
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0191-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026