SCA Pharmaceuticals

38 FDA enforcement actions

38 Total Recalls

0 Class I

35 Class II

3 Class III

Firm Details

Product Types: drug
States: CT

All Recalls

Class II: Risk 07/20/2023 drug

cGMP deviations: due to shipment of rejected units.
Class III: Low Risk 04/10/2023 drug

Subpotent Drug: Out of specification results for low potency was obtained.
Class III: Low Risk 02/24/2023 drug

Subpotent Drug
Class II: Risk 04/25/2022 drug

CGMP Deviations
Class II: Risk 04/25/2022 drug

CGMP Deviations
Class II: Risk 04/25/2022 drug

CGMP Deviations
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class III: Low Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II: Risk 12/17/2020 drug

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

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.