Drug product
S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.
D-0203-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x10 ml dropper bottle
- Official record key
drug-enforcement:D-0203-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05232019DH@04, Exp 8/23/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility