Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

FDA recall notice · announced May 26, 2021 · Sigmapharm Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

Reason for recall

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

Notes

Distribution: Nationwide in the US
Lot/code information: Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022
Quantity: 6266 bottles
Status: Terminated
Products in this recall event:
- Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10 (D-0380-2021)
- Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10. (D-0379-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.