Why it was recalled
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
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.
Lot numbers, UPCs & expiration codes
Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1279-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 14, 2014
- FDA report date
- May 7, 2014
- Quantity
- 667,068 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging
Original FDA data
Every field from FDA enforcement report D-1279-2014, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 67526
- Address
- 13333 Lakefront Dr
- Code information
- Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
- Postal code
- 63045-1514
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1279-2014
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging
- Product quantity
- 667,068 bottles
- Termination date
- Nov 27, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 14, 2014
- Initial firm notification
- Telephone
- Center classification date
- Apr 28, 2014