Recalls / Class III
Class IIID-1396-2019
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.
- Brand name
- Lotemax
- Generic name
- Loteprednol Etabonate
- Active ingredient
- Loteprednol Etabonate
- Route
- Ophthalmic
- NDC
- 24208-503
- FDA application
- NDA202872
- Affected lot / code info
- Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
Why it was recalled
Failed Stability Specifications: Out of specification for viscosity.
Recalling firm
- Firm
- Bausch & Lomb
- Manufacturer
- Bausch & Lomb Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, N/A, Tampa, Florida 33637-1014
Distribution
- Quantity
- 170832 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-06-17
- FDA classified
- 2019-06-19
- Posted by FDA
- 2019-06-19
- Terminated
- 2021-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1396-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.