EMD Serono, Inc. recalls ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, M…
- Recall date
- September 10, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1813-2015
- FDA classification
- Class III
- Brand / firm
- EMD Serono, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class III means the product violates regulations but is not likely to cause harm.
What 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.
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