Cardinal Health Recalls Prenatal Tablets Due to Temperature Excursions
Cardinal Health is recalling 41 bottles of prenatal tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of product degradation due to temperature excursions, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 41 bottles of Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women (NDC 77333-715-10). 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. All lots were distributed between February 23, 2021, and March 10, 2021.
Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.
The recalled product
- Product
- Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 41
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)
- All Lots distributed 02/23/2021 through 03/10/2021.
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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