Drug recall D-0380-2021
Product
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
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
Lots and codes
Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022
Recall details
- Recalling firm
- SigmaPharm Laboratories LLC, Bensalem, PA
- Quantity
- 8786 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 19, 2021
- Terminated
- September 26, 2022
Related products
- Asenapine – drug information
- NDC 42794-016 Asenapine · Asenapine 5 mg/1 · Sigmapharm Laboratories, LLC
- NDC 42794-017 Asenapine · Asenapine 10 mg/1 · Sigmapharm Laboratories, LLC