Cardinal Health Recalls Ibuprofen Oral Suspension Due to Temperature Excursions
Cardinal Health Inc. is recalling 345 cartons of Ibuprofen Oral Suspension USP 100mg/5ml due to intermittent 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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Cardinal Health Inc. is recalling 345 cartons of Ibuprofen Oral Suspension USP 100mg/5ml (NDC 59651-032-12). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product is a prescription medication distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is BO1020069-A.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN ORAL)
- Brand
- IBUPROFEN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Oral Suspension
- Affected units
- 345
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)
- BO1020069-A
UPCs (1)
- 0359651032121
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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