Drug product
S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx
D-0271-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 135x30 ml glass vials
- Official record key
drug-enforcement:D-0271-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05162019DH@12, Exp 8/16/19; S05282019DT@06, Exp 8/28/19; S05302019DT@05, Exp 8/30/19; S06182019DT@03, Exp 9/18/19; S07102019dt@05, Exp 10/10/19; S07162019DT@08, Exp 10/16/19; S07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/19; S06242019DH@01, Exp 9/24/19; S07032019DT@10, EXP 10/03/2019, S07102019DT@05, Exp 10/10/2019, 07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/2019, S07292019DH@15, Exp 10/29/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility