D-0447-2019 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
- 94 vials
Product Description
Thymosin Beta-4, 15 mg Injection, 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: 08302018@8 BUD: 2/26/2019; 10012018@2 BUD: 3/30/2019; 07052018@2 BUD: 01/01/2019