FDAClass IIISeptember 23, 2015

ClomiPHENE CITRATE Tablets recall: Impurity Out of Spec

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…

Why was ClomiPHENE CITRATE Tablets recalled?

Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 233169, Exp 02/16

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…
Recalling firm
EMD Serono, Inc.
Quantity
37,078 cartons
Distribution
Nationwide
Recall date
September 23, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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