Drug product
S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.
D-0262-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x5ml, 7x10ml, 3x11ml, glass vials
- Official record key
drug-enforcement:D-0262-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:S05092019DH@07, Exp 8/9/19; S05082019DT@11, Exp 8/8/19; S07032019DT@13, Exp 10/3/19; S07092019DT@09, Exp 10/9/19; S07292019DH@03, Exp 10/29/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility