Drug product
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
D-1084-2015
Product summary
- Event
- Event 71152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,731 cartons
- Official record key
drug-enforcement:D-1084-2015
Official wording
Reason: Failed pH specification
Code information: Lot# V0814B, Exp 02/16; V1014H, Exp 04/16
Distribution pattern: FL
Derived failure modes
-
Unknown
Failed pH specification