Edge Pharma, LLC

59 FDA enforcement actions

59 Total Recalls

0 Class I

57 Class II

2 Class III

Firm Details

Product Types: drug
States: VT

All Recalls

Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility.
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 12/06/2021 drug

CGMP Deviations
Class II: Risk 12/06/2021 drug

Lack of Assurance of Sterility
Class II: Risk 04/12/2021 drug

Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class III: Low Risk 02/17/2021 drug

Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Class III: Low Risk 12/22/2020 drug

Labeling: Incorrect or Missing Lot and/or Exp Date

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.