The Harvard Drug Group

9 FDA enforcement actions

9 Total Recalls

0 Class I

8 Class II

1 Class III

Firm Details

Product Types: drug
States: TN, MI

All Recalls

Class II: Risk 06/16/2023 drug

Packaging defect: blister packaging inadequately sealed.
Class III: Low Risk 04/24/2023 drug

Product mixup: one foreign tablet found in product.
Class II: Risk 02/23/2023 drug

Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II: Risk 02/28/2022 drug

Failed Dissolution Specifications
Class II: Risk 02/24/2022 drug

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II: Risk 08/06/2021 drug

Failed Dissolution Specifications
Class II: Risk 08/03/2021 drug

Failed Impurities/Degradation Specifications
Class II: Risk 07/29/2021 drug

Failed Dissolution Specifications
Class II: Risk 07/02/2021 drug

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

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.