Cardinal Health Recalls Polyethylene Glycol 3350 Powder for Temperature Excursions
Cardinal Health Inc. is recalling 934 boxes of Polyethylene Glycol 3350 Powder for 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 934 boxes of Polyethylene Glycol 3350 Powder for Solution, an osmotic laxative. The product is identified by NDC 45802-868-66 and consists of 14 once-daily doses (14 packets, 0.5 oz/17g each).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. All lots were distributed between February 23, 2021, and March 10, 2021.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)
- Brand
- POLYETHYLENE GLYCOL 3350
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — OTC Laxative
- Affected units
- 934
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.
See all 198 products in this recall →Related recalls
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