American Health Packaging

8 FDA enforcement actions

8 Total Recalls

0 Class I

5 Class II

3 Class III

Firm Details

Product Types: drug
States: OH

All Recalls

Class III: Low Risk 05/03/2022 drug

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III: Low Risk 04/12/2022 drug

Subpotent Drug: Out of specification for assay.
Class II: Risk 02/22/2022 drug

Impurity failure at 0-time of the repackaged lot.
Class II: Risk 12/20/2021 drug

Failed Dissolution Specifications
Class II: Risk 09/17/2021 drug

Failed Dissolution Specifications: results were above specification.
Class II: Risk 09/15/2021 drug

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class III: Low Risk 05/12/2021 drug

Failed Impurities/Degradation Specifications
Class II: Risk 01/07/2021 drug

Failed Dissolution Specifications

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.