Recalls / Class II
Class IID-1279-2014
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.
- Brand name
- Fluoxetine
- Generic name
- Fluoxetine
- Active ingredient
- Fluoxetine Hydrochloride
- Route
- Oral
- NDCs
- 68645-130, 68645-131
- FDA application
- ANDA076001
- Affected lot / code info
- Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
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.
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging
- Manufacturer
- Legacy Pharmaceutical Packaging, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 13333 Lakefront Dr, Earth City, Missouri 63045-1514
Distribution
- Quantity
- 667,068 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-02-14
- FDA classified
- 2014-04-28
- Posted by FDA
- 2014-05-07
- Terminated
- 2017-11-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1279-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.