Saint Louis, MO, United States
Bausch & Lomb Inc recalls
2 recalls recorded since 2018, most recently on 17 June 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 17 June 2019
- Terminated
- 24 September 2021
- Reason
- Failed Stability Specifications: Out of specification for viscosity.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1396-2019
- 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.
Terminated Class II Medical devices
- Recall started
- 8 August 2018
- Terminated
- 28 August 2019
- Reason
- The back cap separates from the body of the vitrectomy cutter.
- Distribution
- Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Swi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3267-2018, Z-3269-2018, Z-3270-2018, Z-3273-2018, Z-3268-2018, Z-3265-2018, Z-3275-2018, Z-3266-2018, Z-3277-2018, Z-3271-2018, Z-3276-2018, Z-3272-2018 and 1 more
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
- Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
- and 5 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.