Cardinal Health Recalls Penicillin V Potassium Due to Temperature Excursions
Cardinal Health Inc. is recalling 91 bottles of Penicillin V Potassium oral solution due to intermittent temperature excursions during storage.
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, 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 91 bottles of Penicillin V Potassium (Penicillin V Pot) for Oral Solution, USP 125mg/5mL. The product is manufactured for Teva Pharmaceuticals USA, Inc. and is identified by NDC 0093-4125-73.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM)
- Brand
- PENICILLIN V POTASSIUM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antibiotic
- Affected units
- 91
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)
- 35446365A
UPCs (3)
- 0300934125733
- 0300931172013
- 0300934127737
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.
See all 198 products in this recall →Related recalls
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