The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

24 FDA enforcement actions

24 Total Recalls

4 Class I

18 Class II

2 Class III

Firm Details

Product Types: drug
States: TN

All Recalls

Class II: Risk 09/12/2025 drug

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II: Risk 09/12/2025 drug

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II: Risk 09/12/2025 drug

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II: Risk 09/12/2025 drug

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II: Risk 09/12/2025 drug

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II: Risk 09/02/2025 drug

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 09/02/2025 drug

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 08/20/2025 drug

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class II: Risk 04/14/2025 drug

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class III: Low Risk 03/04/2025 drug

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class II: Risk 01/30/2025 drug

Failed Dissolution Specifications.
Class II: Risk 01/21/2025 drug

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II: Risk 01/21/2025 drug

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II: Risk 01/21/2025 drug

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II: Risk 01/13/2025 drug

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Class II: Risk 11/07/2024 drug

Failed Impurity/Degradation Specifications
Class II: Risk 11/07/2024 drug

Failed Impurity/Degradation Specifications
Class III: Low Risk 11/05/2024 drug

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class II: Risk 06/18/2024 drug

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class II: Risk 02/09/2024 drug

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class I: Dangerous 10/31/2023 drug

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I: Dangerous 10/31/2023 drug

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I: Dangerous 10/23/2023 drug

Failed Content Uniformity Specifications
Class I: Dangerous 05/31/2023 drug

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

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.