Recalls / Class III
Class IIID-682-2013
Product
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
- Brand name
- Junel
- Generic name
- Norethindrone Acetate And Ethinyl Estradiol
- Active ingredients
- Ethinyl Estradiol, Norethindrone Acetate
- Route
- Oral
- NDCs
- 0555-9025, 0555-9026, 0555-9027, 0555-9028
- FDA application
- ANDA076380
- Affected lot / code info
- NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
Why it was recalled
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 47,200 blister packs
- Distribution pattern
- Nationwide distribution. No foreign or government accounts.
Timeline
- Recall initiated
- 2013-03-15
- FDA classified
- 2013-07-05
- Posted by FDA
- 2013-07-17
- Terminated
- 2014-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-682-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.