Drug 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.
D-1813-2015
Product summary
- Firm
- EMD Serono, Inc.
- Event
- Event 72172
- Status
- Terminated
- Classification
- Class III
- Quantity
- 37,078 cartons
- Official record key
drug-enforcement:D-1813-2015
Official wording
Reason: Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Code information: Lot #: 233169, Exp 02/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination