FDA recall D-1813-2015

Product

ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.

Reason for recall

Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-10

Report date

2015-09-23

Termination date

2017-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockland, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1813-2015