FDAClass IIIMay 8, 2013

Femhrt recall: Contamination

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner…

Why was Femhrt recalled?

Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

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# 510122B; exp 04/13

Product
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner…
Recalling firm
Warner Chilcott Company LLC
Quantity
27,509 bottles
Distribution
US Nationwide and Puerto Rico
Recall date
May 8, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls