FDAFDA · Food and drugs·Recall number D-0379-2021
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Published May 26, 2021 · Recall initiated: April 19, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ASENAPINE
- Manufacturer
- SigmaPharm Laboratories LLC
- Distributor
- Nationwide in the US
- UPC
- 0342794016103
- Lot
- Lots # 2012501, 2012601 , 2012701, & 2100701, Exp. AUG 2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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