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Prescription drugs recalled for contamination, potency or labelling.
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1,991 recalls · newest first
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Discoloration
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Presence of Particulate Matter: Particulate matter identified as glass
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Subpotent Drug
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Product Mix-up
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Lack of assurance of sterility.
Failed Dissolution Specifications