FDA recall D-1280-2014

Product

Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.

Reason for recall

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-02-12

Report date

2014-05-07

Termination date

2014-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1280-2014