FDA Recalls Dakin's Solution Due to Storage Condition Deviations
McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.
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: This is an FDA Class II recall involving CGMP storage deviations without reported illnesses or injuries. The hazard is theoretical product degradation from improper storage conditions, consistent with a precautionary, moderate-severity recall.
Plain-English summary
Dakin's Solution is a topical antimicrobial product containing sodium hypochlorite in three strength formulations: 0.125%, 0.25%, and 0.5%. McKesson Medical-Surgical Inc. initiated a recall of 113 bottles distributed nationwide.
The FDA classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations. The products were stored outside the conditions specified on their drug labels, which could compromise product stability.
Consumers and healthcare facilities possessing the recalled products should discontinue use. The package identifiers (NDC numbers 0436-0672-16, 0436-0936-16, and 0436-0946-16) can assist in identifying recalled units. No illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- DAKINS QUARTER (SODIUM HYPOCHLORITE)
- Brand
- DAKINS QUARTER
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Antimicrobial
- Hazard
- improper-storage
- stability-concern
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0304360936161
- 0304360946160
Distribution
Distributed nationwide across the United States.
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