Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Reported: May 26, 2021 Initiated: April 19, 2021 #D-0379-2021
Product Description
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
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
Details
- Recalling Firm
- SigmaPharm Laboratories LLC
- Units Affected
- 6266 bottles
- Distribution
- Nationwide in the US
- Location
- Bensalem, PA
Frequently Asked Questions
What product was recalled? ▼
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.. Recalled by SigmaPharm Laboratories LLC. Units affected: 6266 bottles.
Why was this product recalled? ▼
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 26, 2021. Severity: Low. Recall number: D-0379-2021.
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