Teva Recalls Balziva Tablets Due to Impurity Detection
Teva Pharmaceuticals is recalling Balziva (norethindrone and ethinyl estradiol) tablets because an impurity was detected during testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard is a chemical impurity detected during testing, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 36,708 blister packs of Balziva (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg. The recall involves specific lot numbers with expiration dates in March 2013 and August 2013. The product was distributed nationwide to commercial accounts, with no foreign or government distribution.
The recall was initiated because an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing. This finding resulted in a failure of the impurity/degradation specification for the product.
Consumers and healthcare providers should stop using the affected lots of Balziva and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recalled product should be returned to the pharmacy or point of purchase for disposal or credit.
The recalled product
- Product
- BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
- Brand
- BALZIVA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 36,708
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- NDC 0555-9034-58
- Lot numbers 33802100A
- exp 3/2013
- 33802266A
- and 33802832A
- exp 8/2013.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teva Pharmaceuticals USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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