17,898 recalls, newest first
Reason Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Reason Discoloration
Reason Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Reason Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Reason Presence of Particulate Matter: Particulate matter identified as glass
Reason Subpotent Drug
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Reason Product Mix-up
Reason Lack of assurance of sterility.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications