Why it was recalled
Failed Stability Specifications: Out of specification for viscosity.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1396-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 17, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 170832 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch & Lomb
Original FDA data
Every field from FDA enforcement report D-1396-2019, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83093
- Address
- 8500 Hidden River Pkwy
- Code information
- Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
- Postal code
- 33637-1014
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1396-2019
- Classification
- Class III
- Recalling firm
- Bausch & Lomb
- Product quantity
- 170832 bottles
- Termination date
- Sep 24, 2021
- Reason for recall
- Failed Stability Specifications: Out of specification for viscosity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jun 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 19, 2019