Fluvastatin Capsule
FDA Recall NDC 0093-7442
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 Fluvastatin (NDC 0093-7442). A significant event, classified as Class II, was initiated on May 29, 2014 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage."
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
Class II Terminated
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
May 29, 2014
Jul 16, 2014
8,472 Bottles
Recall Profile & Regulatory Data
Event ID
68441
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Termination Date
Mar 09, 2015
Product Description
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
Batch or Lot Expiration Information
Lot# : F47008, Exp. 7/2015
Affected Packages Involved in this Recall
0093-7442-56Product
0093-7442-01Product
0093-7443-56Product
0093-7443-01Product
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.
