Drug product
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
D-0803-2021
Product summary
- Event
- Event 88662
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57 vials
- Official record key
drug-enforcement:D-0803-2021
Official wording
Reason: Lack of processing controls
Code information: Lot# 06152021@2, Exp 09/13/2021
Distribution pattern: AZ, CO, FL, IL, NJ
Derived failure modes
-
Manufacturing or process control
Lack of processing controls