D-0481-2019 Class II Terminated
FDA drug recall D-0481-2019 was initiated by Promise Pharmacy, LLC on December 17, 2018 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated March 30, 2021). Affected quantity: 1 10 ml vial.
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
- 1 10 ml vial
Product Description
Folic Acid, 5mg/ml injection, 10ml vial, 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
Lot: 10302018@8, BUD 12/14/2018