SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-
Recalled May 26, 2021 · FDA recall D-0379-2021 · SigmaPharm Laboratories
Hazard
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent · FDA Class III
Units
6266 bottles
Sold at
Nationwide in the US
Description
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Product
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Manufacturer(s)
SigmaPharm Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →