D-1279-2014 Class II Terminated

Recalled by Legacy Pharmaceutical Packaging — Earth City, MO

FDA drug recall D-1279-2014 was initiated by Legacy Pharmaceutical Packaging on Feb 14, 2014 and is designated Class II. 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. The recall status is terminated (terminated Nov 27, 2017). Affected quantity: 667,068 bottles.

Recall Details

Product Type
Drugs
Report Date
May 7, 2014
Initiation Date
Feb 14, 2014
Termination Date
Nov 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
667,068 bottles

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.

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.

Distribution Pattern

Nationwide

Code Information

Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1279-2014
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1279-2014. Report a data issue: hello@regdatalab.com.