Drug product
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0443-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 704 vials
- Official record key
drug-enforcement:D-0443-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 08032018@3 BUD: 01/30/2019; 08272018@6 BUD: 2/23/2019; 09142018@4 BUD: 3/13/2019; 10012018@3 BUD: 3/30/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility