Recalls / Class II
Class IID-0880-2017
Product
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
- Brand name
- Saphris
- Generic name
- Asenapine Maleate
- Active ingredient
- Asenapine Maleate
- Route
- Sublingual
- NDCs
- 0456-2402, 0456-2405, 0456-2410
- FDA application
- NDA022117
- Affected lot / code info
- Lots W00733 and W00946, exp Apr 2019
Why it was recalled
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Recalling firm
- Firm
- Forest Laboratories, LLC
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborside Financial Center, Plaza V- Suite 1900, Jersey City, New Jersey 07311
Distribution
- Quantity
- 40,621 blister packs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-05-18
- FDA classified
- 2017-05-31
- Posted by FDA
- 2017-06-07
- Terminated
- 2018-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0880-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.