Fluoxetine Capsule
FDA Recall NDC 68645-130
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 Fluoxetine (NDC 68645-130). A significant event, classified as Class II, was initiated on Feb 14, 2014 by Legacy Pharmaceutical Packaging, Llc. The reported reason for this action was: "Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor."
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
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Feb 14, 2014
May 07, 2014
667,068 bottles
Recall Profile & Regulatory Data
Event ID
67526
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Legacy Pharmaceutical Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 27, 2017
Product Description
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.
Batch or Lot Expiration Information
Lot# Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
Affected Packages Involved in this Recall
68645-131-54Product
68645-130-54Product
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.
