Class II · Moderate risk
Multihance Multipack
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
ChloraPrep with Tint
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Class II · Moderate risk
Murocel (methylcellulose)
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 the 12 month stability time point.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Lack of Assurance of Sterility
Class I · High risk
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.