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.
Reported: June 19, 2019 Initiated: June 17, 2019 #D-1396-2019
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.
Details
- Recalling Firm
- Bausch & Lomb
- Units Affected
- 170832 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Tampa, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bausch & Lomb. Units affected: 170832 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification for viscosity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Low. Recall number: D-1396-2019.
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