Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex…
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
233 FDA recalls mention Wood. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Wood.
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Reason Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Reason Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Reason Non-Sterility; microbial contamination identified as Bacillus circulans
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Reason Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Reason Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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