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All product recalls associated with Direct Rx.
Total Recalls
36
Past Year
3
Class I (Serious)
0
Most Recent
Mar 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Failed impurities/degradation specifications
Defective Container: Leaking containers.
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.