SigmaPharm Laboratories LLC

4 FDA enforcement actions

4 Total Recalls

0 Class I

2 Class II

2 Class III

Firm Details

Product Types: drug
States: PA

All Recalls

Class II: Risk 09/21/2021 drug

Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II: Risk 08/13/2021 drug

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class III: Low Risk 04/19/2021 drug

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III: Low Risk 04/19/2021 drug

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

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.