Home / Recalls / EMD Serono, Inc. / D-1813-2015

D-1813-2015 Class III Terminated

Recalled by EMD Serono, Inc. — Rockland, MA

Recall Details

Product Type: Drugs
Report Date: September 23, 2015
Initiation Date: September 10, 2015
Termination Date: February 13, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 37,078 cartons

Product Description

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 Pattern

Nationwide

Code Information

Lot #: 233169, Exp 02/16