Western Drug Recalls Butor/Nal/Hydro Nasal Suspension Due to Sterility Concerns
Western Drug is recalling two containers of Butor/Nal/Hydro Nasal Suspension because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a nasal suspension) map to a score of 4 (Severe).
Plain-English summary
Western Drug Inc. is recalling two containers of Butor/Nal/Hydro Nasal Suspension, a prescription medication. The recall is being conducted because the product lacks assurance of sterility. This issue affects all lots of the product.
The recalled product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall number is D-0400-2016.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The FDA classifies this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Nasal Suspension
- Hazard
- Affected units
- 2
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
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug 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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