Recall: D-1396-2019

Class III - Minor Violations

Class IIIClassification

2019-06-17Initiated

TerminatedStatus

Bausch & LombFirm

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.

Reason

Failed Stability Specifications: Out of specification for viscosity.

Distribution

Nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.