Class III ยท Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
National Drug Code
Is NDC 42794-0016-10 recalled?
Asenapine · 60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10)
Yes — this exact package was recalled
1 FDA recall names the code 42794-0016-10 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Asenapine
- Strength
- ASENAPINE 5 mg/1
- Form
- Tablet · Sublingual
- Labeler
- Sigmapharm Laboratories, LLC
- Type
- Human Prescription Drug
- Product code
- 42794-0016
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 42794-0018 Liothyronine Sodium 2
- 42794-0086 See recall 2
- 42794-0017 Asenapine 1
- 42794-0019 Liothyronine Sodium 1
Free recall alerts
Know the day your medication is recalled
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