Class II · Moderate risk Ongoing
Alyacen 7/7/7
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Jevantique
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was 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 was recalled
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
- Recalling firm
- Warner Chilcott Company LLC
- NDC code
- 52544-237-19
- Origin
- PR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-304-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Ongoing
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Reason Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk Ongoing
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Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
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Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
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Reason Presence of Foreign substance - potential presence of metal particulate matter
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