D-1396-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- June 17, 2019
- Termination Date
- September 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170832 bottles
Product Description
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.
Reason for Recall
Failed Stability Specifications: Out of specification for viscosity.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.