FDA Recalls A&D Original Ointment due to improper storage conditions
A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.
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 for storage outside drug label specifications (CGMP deviation). No illnesses, injuries, or hospitalizations have been reported. The hazard is regulatory non-compliance with theoretical but not yet documented consequences.
Plain-English summary
A&D Original Ointment, a diaper rash ointment and skin protectant sold in 16 oz jars, is being recalled nationwide because the products were stored outside the specifications set on the drug label. This storage deviation violates Current Good Manufacturing Practice (CGMP) standards.
The recalled product is identified by National Drug Code (NDC) 11523-0096-3 and was distributed nationwide throughout the United States. The recall was issued by McKesson Medical-Surgical Inc. Corporate Office for the Bayer Healthcare Pharmaceuticals branded product.
No illnesses or injuries have been reported as a result of this recall. Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist about obtaining a replacement. The product should be returned to the place of purchase or disposed of according to local regulations.
The recalled product
- Product
- A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical / Skin Care
- Hazard
- improper-storage
- cgmp-deviation
Distribution
Distributed nationwide across the United States.
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