Forest Laboratories, LLC recalls Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by:…

Recall date

May 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0880-2017

FDA classification

Class II

Brand / firm

Forest Laboratories, LLC

Sold / distributed

Nationwide

Why it was recalled

Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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