Drug product
S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx
D-0279-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0279-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b) S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility