243 FDA recalls mention Carbo. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carbo.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: identified as glass.
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the…
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the…
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
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