SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-…
- Recall date
- April 19, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0380-2021
- FDA classification
- Class III
- Brand / firm
- SigmaPharm Laboratories LLC
- Sold / distributed
- Nationwide in the US
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
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Get recall alerts
Free email alert whenever SigmaPharm Laboratories LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: SigmaPharm Laboratories LLC