Drug product
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
D-0060-2023
Product summary
- Firm
- ImprimisRx NJ
- Event
- Event 91140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 960 bottles
- Official record key
drug-enforcement:D-0060-2023
Official wording
Reason: Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Code information: Lot # 06272022@3, Exp. date 11/24/2022 Lot # 08302022@1, Exp. date 01/27/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent