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.
Junel
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
What was recalled
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- NDC code
- 0555-9028-58
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-682-2013
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.
Other Estradiol recalls
See all
Class II · Moderate risk Ongoing
Estradiol Gel
Reason Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Estradiol
Reason Presence of Foreign substance - potential presence of metal particulate matter
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.