Status
Terminated
Drug Enforcement D-684-2013
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Classification
Class III
Report Date
July 17, 2013
Termination Date
April 10, 2014
Product Information
- Product description
- Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
- Product quantity
- 36,708 blister packs
- Reason for recall
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide distribution. No foreign or government accounts.
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-684-2013
- Event ID
- 64644
- Recall initiation date
- March 15, 2013
- Center classification date
- July 5, 2013
- Code info
- NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.
- More code info
- —