Recalls / Class III
Class IIID-0380-2021
Product
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
- Brand name
- Asenapine
- Generic name
- Asenapine
- Active ingredient
- Asenapine
- Route
- Sublingual
- NDCs
- 42794-016, 42794-017
- FDA application
- ANDA206107
- Affected lot / code info
- Lots # 2012801, 2012901, 2013001 & Lot 2100501, Exp AUG 2022; 2100101, Exp NOV 2022
Why it was recalled
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Recalling firm
- Firm
- SigmaPharm Laboratories LLC
- Manufacturer
- Sigmapharm Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3375 Progress Dr, N/A, Bensalem, Pennsylvania 19020-5801
Distribution
- Quantity
- 8786 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-04-19
- FDA classified
- 2021-05-14
- Posted by FDA
- 2021-05-26
- Terminated
- 2022-09-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0380-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.