D-0446-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- December 17, 2018
- Termination Date
- March 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196 50 ml vials
Product Description
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: 10152018@1 BUD: 1/13/2019; 10312018@2 BUD: 1/29/2019