Drug product
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
D-1133-2017
Product summary
- Event
- Event 77647
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bottles
- Official record key
drug-enforcement:D-1133-2017
Official wording
Reason: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Code information: 05092017@2B, 11/5/2017
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeling