Cardinal Health Recalls Acetazolamide Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 122 bottles of Acetazolamide Tablets 125 mg 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 is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 122 bottles of Acetazolamide Tablets, USP 125 mg (NDC 23155-287-01). The product is a prescription-only medication manufactured for Heritage Pharmaceuticals Inc. The recall is limited to 122 bottles with lot number M200833.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving 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
- ACETAZOLAMIDE (ACETAZOLAMIDE)
- Brand
- ACETAZOLAMIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 122
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)
- M200833
UPCs (4)
- 0323155288018
- 0323155288100
- 0323155287011
- 0323155287103
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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