SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794
Recalled May 26, 2021 · FDA recall D-0380-2021 · 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
8786 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, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Manufacturer(s)
SigmaPharm Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →