FDA-Drug2021-05-26Class III
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
SigmaPharm Laboratories LLC
Hazard
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Sold states
Nationwide in the US
Affected count
6266 bottles
Manufactured in
3375 Progress Dr, N/A, Bensalem, PA, United States
Products
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0379-2021Don't want to check this manually?
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