Reported Jun 19, 2019 · Terminated
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant…
Bausch & Lomb
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb · 8500 Hidden River Pkwy · Tampa, FL · 33637-1014
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: 282611283431283441283451Exp. 10/2019282971282981283611283621283631Exp. 11/2019
- Amount recalled
- 170832 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of specification for viscosity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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