D-0431-2019 Class II Terminated
FDA drug recall D-0431-2019 was initiated by Promise Pharmacy, LLC on Dec 17, 2018 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 75 10 ml bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 20, 2019
- Initiation Date
- Dec 17, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 10 ml bottles
Product Description
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 11072018@10 BUD: 12/22/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0431-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026