FDAFDA · Food and drugs·Recall number D-0880-2017
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
Published June 7, 2017 · Recall initiated: May 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SAPHRIS
- Manufacturer
- Forest Laboratories, LLC
- Distributor
- Nationwide
- Lot
- Lots W00733 and W00946, exp Apr 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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