Recall: D-0379-2021
Class III - Minor Violations
Class IIIClassification
2021-04-19Initiated
TerminatedStatus
SigmaPharm Laboratories LLCFirm
Product
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Reason
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Distribution
Nationwide in the US
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.