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
Reported: June 7, 2017 Initiated: May 18, 2017 #D-0880-2017
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
Details
- Recalling Firm
- Forest Laboratories, LLC
- Units Affected
- 40,621 blister packs
- Distribution
- Nationwide
- Location
- Jersey City, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Forest Laboratories, LLC. Units affected: 40,621 blister packs.
Why was this product recalled? ▼
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2017. Severity: Moderate. Recall number: D-0880-2017.
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