Recalls / Class III
Class IIID-1813-2015
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.
- Affected lot / code info
- Lot #: 233169, Exp 02/16
Why it was recalled
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Recalling firm
- Firm
- EMD Serono, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Technology Pl, Rockland, Massachusetts 02370-1071
Distribution
- Quantity
- 37,078 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-09-10
- FDA classified
- 2015-09-15
- Posted by FDA
- 2015-09-23
- Terminated
- 2017-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1813-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.