FDA-Drug2015-09-23Class III
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.
EMD Serono, Inc.
Hazard
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Sold states
Nationwide
Affected count
37,078 cartons
Manufactured in
1 Technology Pl, Rockland, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1813-2015Don't want to check this manually?
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