Reported Jun 7, 2017 · Terminated
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by:…
Forest Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Forest Laboratories, LLC · Harborside Financial Center · Jersey City, NJ · 07311
Is this the product you have?
- Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor
- Manufactured byCatalent 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
- Lot codes and dates
Lots W00733 and W00946exp Apr 2019
- Amount recalled
- 40,621 blister packs
Where it was sold
- 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
This product could cause temporary or reversible health problems — stop using it.
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