Drug 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
D-0880-2017
Product summary
- Event
- Event 77315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,621 blister packs
- Official record key
drug-enforcement:D-0880-2017
Official wording
Reason: Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Code information: Lots W00733 and W00946, exp Apr 2019
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup