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
Reported: July 17, 2013 Initiated: March 15, 2013 #D-684-2013
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
Reason for Recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 36,708 blister packs
- Distribution
- Nationwide distribution. No foreign or government accounts.
- Location
- Sellersville, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 36,708 blister packs.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2013. Severity: Low. Recall number: D-684-2013.
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