Drug product
S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX
D-0240-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60x 10 and 30 ML glass vials
- Official record key
drug-enforcement:D-0240-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S05162019DH@10, EXP 08/16/2019,S05242019DT@07, EXP 8/24/19, S07182019DT@14 EXP 10/18/19, b) S05162019DH@18, Exp 8/16/19;S07102019DT@04, EXP 10/10/19,S07262019DH@10 EXP 10/26/19, S07292019DH@10 EXP 10/29/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility