Drug product
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
D-0201-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6x10 ml, 1x50 ml dropper bottle
- Official record key
drug-enforcement:D-0201-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S06112019DH@22, Exp 9/11/19; S06202019DT@10, Exp 9/20/19; S07312019DH@07, Exp 10/31/19; b) S07302019DH@07, Exp 10/30/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility