Saphris Tablet
FDA Recall NDC 0456-2402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Saphris (NDC 0456-2402). A significant event, classified as Class II, was initiated on May 18, 2017 by Allergan, Inc.. The reported reason for this action was: "Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2017 Class II Recall: Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Recall Number
Class II Terminated
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
May 18, 2017
Jun 07, 2017
40,621 blister packs
Recall Profile & Regulatory Data
Event ID
77315
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Forest Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 15, 2018
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
Batch or Lot Expiration Information
Lot# Lots W00733 and W00946, exp Apr 2019
Affected Packages Involved in this Recall
0456-2402-10Product
0456-2402-06Product
0456-2402-60Product
0456-2402-11Product
0456-2402-63Product
0456-2405-10Product
0456-2405-06Product
0456-2405-60Product
0456-2405-11Product
0456-2405-63Product
0456-2410-10Product
0456-2410-06Product
0456-2410-60Product
0456-2410-11Product
0456-2410-63Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
