Drug recall D-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
Reason for recall
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Lots and codes
Lots W00733 and W00946, exp Apr 2019
Recall details
- Recalling firm
- Forest Laboratories, LLC, Jersey City, NJ
- Quantity
- 40,621 blister packs
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 18, 2017
- Terminated
- November 15, 2018
Related products
- Saphris – drug information
- NDC 0456-2402 Saphris · Asenapine Maleate 2.5 mg/1 · Allergan, Inc.
- NDC 0456-2410 Saphris · Asenapine Maleate 10 mg/1 · Allergan, Inc.
- NDC 0456-2405 Saphris · Asenapine Maleate 5 mg/1 · Allergan, Inc.