Drug product
S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
D-0266-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11x 5ml and 10ml glass vials
- Official record key
drug-enforcement:D-0266-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S06112019DH@10, Exp 8/11/19; b) S06112019DH@10, Exp 8/11/19, S06142019DH@03, Exp 8/14/19, S06252019DH@14, Exp 8/25/19, S07222019DH@02, Exp 9/22/19,
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility