Arzol Silver Nitrate Applicator Recalled for Temperature-Related Manufacturing Defects
McKesson Medical-Surgical is recalling Arzol silver nitrate applicators nationwide due to temperature abuse during manufacturing that may affect product quality.
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: FDA Class II recall with no reported illnesses or injuries. The temperature abuse during manufacturing represents a manufacturing defect affecting current Good Manufacturing Practice standards, making this a precautionary recall without evidence of actual harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Arzol (Silver Nitrate Applicator) with NDC 12870-0001-02 due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse.
The recalled product is a prescription-only silver nitrate applicator containing 75% silver nitrate and 25% potassium nitrate in 100-count boxes. The product was distributed nationwide in the United States.
Temperature abuse during the manufacturing process represents a deviation from current Good Manufacturing Practice standards that may compromise product quality, stability, or intended performance. No illnesses or injuries related to this recall have been reported to the FDA at this time.
Consumers and healthcare providers who have received this product should not use it and should contact McKesson Medical-Surgical for return instructions. Healthcare facilities should verify whether they have received affected product based on the distribution dates provided in McKesson's correspondence.
The recalled product
- Product
- Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol Chemical Co, NDC 12870-0001-02
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Affected units
- 18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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