RemedyRePack Inc.

34 FDA enforcement actions

34 Total Recalls

0 Class I

34 Class II

0 Class III

Firm Details

Product Types: drug
States: PA

All Recalls

Class II: Risk 04/22/2025 drug

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II: Risk 03/24/2025 drug

CGMP Deviations
Class II: Risk 01/24/2025 drug

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II: Risk 12/02/2024 drug

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 06/26/2024 drug

CGMP Deviations: Out of specification for dissolution
Class II: Risk 05/31/2024 drug

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II: Risk 05/02/2024 drug

Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Class II: Risk 05/01/2023 drug

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II: Risk 05/01/2023 drug

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II: Risk 05/01/2023 drug

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 03/20/2023 drug

cGMP Deviations
Class II: Risk 12/20/2022 drug

Failed Impurities/Degradation specifications
Class II: Risk 12/05/2022 drug

Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class II: Risk 09/15/2022 drug

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II: Risk 05/04/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 05/02/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II: Risk 05/02/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II: Risk 04/06/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II: Risk 12/30/2021 drug

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II: Risk 12/29/2021 drug

Failed Impurities/Degradation Specifications
Class II: Risk 08/17/2021 drug

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

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.