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 Failed stability specifications: Out of specification for hardness test
Reason Lack of Assurance of Sterility.
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Reason cGMP deviations and lack of assurance of sterility.
Reason cGMP deviations and lack of assurance of sterility.
Reason Lack of Assurance of Sterility
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason LABELING: LABEL MIX-UP
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Reason Subpotent Drug: Out of specification for assay
Reason Presence of Particulate Matter; identified as glass
Reason Presence of Particulate Matter; identified as glass
Reason Non-Sterility
Reason Non-Sterility
Reason Non-Sterility
Reason Non-Sterility
Reason Non-Sterility
Reason Non-Sterility
Reason Non-Sterility
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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