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U.S. Department of Health and Human Services

Enforcement Report - Week of May 7, 2014

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Product Detail

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.
Recall Number D-1279-2014
Classification Class II
Code Info Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
Product Distributed Qty 667,068 bottles
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.

Event Detail

Event Id 67526
Product Type Drugs
Status Ongoing
Recalling Firm Legacy Pharmaceutical Packaging
City Earth City
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-14
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide