Direct Rx

31 FDA enforcement actions

31 Total Recalls

0 Class I

31 Class II

0 Class III

Firm Details

Product Types: drug
States: GA

All Recalls

Class II: Risk 03/07/2025 drug

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 03/07/2025 drug

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 01/31/2025 drug

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II: Risk 08/09/2024 drug

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II: Risk 03/22/2023 drug

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II: Risk 03/22/2023 drug

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II: Risk 03/22/2023 drug

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 03/13/2023 drug

cGMP deviations
Class II: Risk 11/02/2022 drug

cGMP deviation: discontinue of stability support for product.
Class II: Risk 09/12/2022 drug

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II: Risk 05/13/2022 drug

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II: Risk 05/11/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II: Risk 05/11/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II: Risk 05/11/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II: Risk 05/05/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 03/04/2022 drug

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II: Risk 03/04/2022 drug

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II: Risk 02/17/2022 drug

Failed impurities/degradation specifications
Class II: Risk 12/07/2021 drug

Defective Container: Leaking containers.
Class II: Risk 09/14/2021 drug

CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II: Risk 03/02/2021 drug

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.