SigmaPharm Laboratories LLC: Drug Recall
Recall #D-0379-2021 · 04/19/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0379-2021
- 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
- 6266 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, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
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.