D-1279-2014 Class II Terminated
FDA drug recall D-1279-2014 was initiated by Legacy Pharmaceutical Packaging on February 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 November 27, 2017). Affected quantity: 667,068 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- February 14, 2014
- Termination Date
- November 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