Class III · 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
Saphris 10 mg (Asenapine Maleate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
Affected NDCs
0456-2410-06
0456-2410-60
Compare with the code on your package — it is the most precise check available.
Drug: Asenapine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Saphris Asenapine Maleate NDC 00456-2410 |
10 mg/1 | Tablet Sublingual |
Allergan, Inc. | Rx |
- Recalling firm
- Forest Laboratories, LLC
- NDC code
- 0456-2410-60
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0880-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Asenapine recalls
See all
Class III · 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
Other labeling / mix-up recalls from 2017
All labeling / mix-up recalls
Class II · Moderate risk
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class III · Low risk
Enoxaparin Sodium
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class II · Moderate risk
Gabapentin Tablets
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg)
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
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