Amneal Pharmaceuticals of New York, LLC

11 FDA enforcement actions

11 Total Recalls

1 Class I

9 Class II

1 Class III

Firm Details

Product Types: drug
States: NY

All Recalls

Class II: Risk 03/25/2024 drug

Failed Dissolution Specifications
Class I: Dangerous 03/21/2024 drug

Superpotent Drug: Due to overfilling of drug powder
Class II: Risk 02/13/2024 drug

Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II: Risk 01/15/2024 drug

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II: Risk 12/26/2023 drug

Failed dissolution specifications
Class II: Risk 10/27/2023 drug

Failed Dissolution Specifications
Class II: Risk 05/30/2023 drug

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class III: Low Risk 05/08/2023 drug

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class II: Risk 07/27/2022 drug

Failed dissolution specifications.
Class II: Risk 11/04/2021 drug

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II: Risk 11/04/2021 drug

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

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.