Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
17 FDA recalls mention Daptomycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Daptomycin.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Lack of sterility assurance
Reason Lack of sterility assurance
Reason Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Reason Presence of Particulate Matter: Identified as Glass Particles
Reason Presence of Particulate Matter
Reason Lack Of Processing Controls
Reason Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to…
Reason Lack of Sterility Assurance
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Lack of sterility assurance.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Reason Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Reason Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Reason Presence of Particulate Matter; Glass particulates observed in vials
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