The Recall Desk
ModerateFDA (Drugs)·D-1006-2022·Announced 2022-06-15

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.

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: 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
Hazard
  • manufacturing-defect
  • temperature-abuse

Distribution

Distributed nationwide across the United States.