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Recall Observatory FDA recall evidence

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

June 17, 2019

Class III

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

    reason.potency_specification_failure · v1.0.0

    Out of specification