Why it was recalled
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
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.
Lot numbers, UPCs & expiration codes
Lot #: 233169, Exp 02/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1813-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 10, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 37,078 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EMD Serono, Inc.
Original FDA data
Every field from FDA enforcement report D-1813-2015, exactly as published.
Show all FDA fields
- City
- Rockland
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 72172
- Address
- 1 Technology Pl
- Code information
- Lot #: 233169, Exp 02/16
- Postal code
- 02370-1071
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1813-2015
- Classification
- Class III
- Recalling firm
- EMD Serono, Inc.
- Product quantity
- 37,078 cartons
- Termination date
- Feb 13, 2017
- Reason for recall
- Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2015