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.
Reported: September 23, 2015 Initiated: September 10, 2015 #D-1813-2015
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.
Details
- Recalling Firm
- EMD Serono, Inc.
- Units Affected
- 37,078 cartons
- Distribution
- Nationwide
- Location
- Rockland, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by EMD Serono, Inc.. Units affected: 37,078 cartons.
Why was this product recalled? ▼
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 23, 2015. Severity: Low. Recall number: D-1813-2015.
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