Bausch & Lomb recalls
FDA enforcement reports naming Bausch & Lomb as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Jun 19, 2019
- Jun 19, 2019Lotemax (loteprednol etabonate ophthalmic gel 0Drug · Bausch & LombFailed Stability Specifications: Out of specification for viscosity.Class III
- Jun 21, 2017NasalCrom (cromolyn sodium) Nasal Spray, USP, 5Drug · Bausch & Lomb, Inc.CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.Class II
- Feb 3, 2016Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59…Drug · Bausch & Lomb, Inc.Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.Class III
- Feb 3, 2016Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (…Drug · Bausch & Lomb, Inc.Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.Class III
- Feb 3, 2016Tropicamide Ophthalmic Solution USP, 0Drug · Bausch & Lomb, Inc.Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.Class III
- Aug 26, 2015Bromfenac Ophthalmic Solution, 0Drug · Bausch & Lomb, Inc.Lack of Assurance of Sterility: Failed preservative effectiveness testing.Class II
- Jul 2, 2014Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tu…Drug · Bausch & Lomb, Inc.Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.Class II
- Jul 2, 2014Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 ozDrug · Bausch & Lomb, Inc.Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.Class II
- Jun 20, 2012Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Ma…Drug · Bausch & Lomb, Inc.Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at t…Class II