Drug product
Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0442-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 252 vials
- Official record key
drug-enforcement:D-0442-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 08212018@11 BUD: 12/19/2018; 10012018@1 BUD: 1/29/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility