Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
893 recalls · Class II, newest first
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of Assurance of Sterility and cGMP Deviations
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Presence of Particulate Matter
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.