SigmaPharm Laboratories LLC: Drug Recall
Recall #D-0380-2021 · 04/19/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0380-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- SigmaPharm Laboratories LLC
- Status
- Terminated
- Date Initiated
- 04/19/2021
- Location
- Bensalem, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8786 bottles
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
Product Description
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Distribution Pattern
Nationwide in the US
Other Recalls by SigmaPharm Laboratories LLC
- Class II: Risk 09/21/2021
- Class II: Risk 08/13/2021
- Class III: Low Risk 04/19/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.