Cardinal Health Recalls Balziva Due to Temperature Excursions
Cardinal Health Inc. is recalling 23 bottles of Balziva (norethindrone and ethinyl estradiol) due to intermittent exposure to temperature excursions during storage.
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 recall is classified as FDA Class II, and the hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 23 bottles of Balziva (norethindrone and ethinyl estradiol tablets USP), 28 Day, 6 Blister Card Dispensers, 28 tablets each. The product is a prescription-only medication manufactured for Teva Pharmaceuticals USA, Inc. The recall is limited to NDC 0555-9034-58 with code 100016785.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers with this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
- Brand
- BALZIVA
- Manufacturer
- Cardinal Health Inc.
- Affected units
- 23
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 (1)
- 100016785
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health 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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