Home / Recalls / Bausch & Lomb, Inc. / D-1349-2015

D-1349-2015 Class II Terminated

Recalled by Bausch & Lomb, Inc. — Tampa, FL

Recall Details

Product Type
Drugs
Report Date
August 26, 2015
Initiation Date
August 17, 2015
Termination Date
April 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,995 Bottles

Product Description

Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

Reason for Recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing.

Distribution Pattern

U.S. Nationwide and Puerto Rico

Code Information

Lot #221211, Expiry: 09/30/2015

Other recalls by Bausch & Lomb, Inc.

  • D-1396-2019 Class III — Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, (June 17, 2019)
  • Z-3266-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Fi (August 8, 2018)
  • Z-3270-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-F (August 8, 2018)
  • Z-3277-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Fi (August 8, 2018)
  • Z-3265-2018 Class II — Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged (August 8, 2018)
  • Z-3272-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Fi (August 8, 2018)
  • Z-3275-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Fi (August 8, 2018)
  • Z-3267-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-F (August 8, 2018)
  • Z-3269-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Fi (August 8, 2018)
  • Z-3276-2018 Class II — Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Fie (August 8, 2018)