Drug product
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
D-1132-2017
Product summary
- Event
- Event 77647
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-1132-2017
Official wording
Reason: Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Code information: 04042017@34B, 10/01/2017
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeling