FDA Drug recall D-1813-2015
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israe…
- FDA Drug
- Class III
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class III recall of ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israe… by Emd Serono, citing chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1813-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-09-10 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Emd Serono |
| Distribution | US |
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.
Reason
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Identifiers
| upc | 300930041037 |
|---|---|
| code_info | Lot #: 233169, Exp 02/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1813-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.