Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (N...

FDA Drug Recall #D-303-2013 — Class III — February 15, 2013

Recall Summary

Recall Number D-303-2013
Classification Class III — Low risk
Date Initiated February 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Warner Chilcott Company LLC
Location Fajardo, PR
Product Type Drugs
Quantity 27,509 bottles

Product Description

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 Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866

Reason for Recall

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.

Distribution Pattern

US Nationwide and Puerto Rico

Lot / Code Information

Lot# 510122B; exp 04/13

Other Recalls from Warner Chilcott Company LLC

Recall # Classification Product Date
D-305-2013 Class III Femhrt (norethindrone acetate and ethinyl estra... Feb 15, 2013
D-304-2013 Class III Jevantique (norethindrone acetate and ethinyl e... Feb 15, 2013
D-142-2013 Class III Femtrace 0.45 mg (Estradiol Acetate) Tablets, R... Dec 21, 2012
D-141-12013 Class III Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx... Dec 21, 2012

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.