Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class IIIReported terminated
Distribution: Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class IIReported terminated
Distribution: Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Subpotent Drug and Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
These examples come from this result page and are not a ranking of every recall reason.
Checking Lupin Pharmaceuticals Inc.
Is there a recall on lupin pharmaceuticals inc. right now?
This archive contains 54 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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