Drug product
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
D-1396-2019
Product summary
- Firm
- Bausch & Lomb
- Event
- Event 83093
- Status
- Terminated
- Classification
- Class III
- Quantity
- 170832 bottles
- Official record key
drug-enforcement:D-1396-2019
Official wording
Reason: Failed Stability Specifications: Out of specification for viscosity.
Code information: Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out of specification