D-0880-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- May 18, 2017
- Termination Date
- November 15, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,621 blister packs
Product Description
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
Reason for Recall
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Distribution Pattern
Nationwide
Code Information
Lots W00733 and W00946, exp Apr 2019