192 FDA recalls mention Sage. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sage.
Reason Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Reason Failed Impurities/Degradation Specifications
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a…
Reason Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability…
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
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
Reason Lack of Assurance of Sterility
Reason Labeling: Not elsewhere classified
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