February 2014 FDA Recall Fluoxetine by Legacy Pharmaceutical Packaging
D-1279-2014 - Chemical Contamination

This Class II drug recall was voluntarily initiated by Legacy Pharmaceutical Packaging on February 14, 2014 for the product Fluoxetine. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1279-2014

Reason for Recall
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Initiated
02-14-2014
Reported
05-07-2014
Quantity
667,068 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67526
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Legacy Pharmaceutical Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-27-2017
Product Description About Product Description
Full technical description of the product.
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

68645-131-54 Fluoxetine
68645-130-54 Fluoxetine