Western Drug Recalls Dexpanthanol B5 Injection Due to Sterility Concerns
Western Drug is recalling four containers of Dexpanthanol B5 250mg/mL Injection 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no injuries are reported, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the hazard is substantial.
Plain-English summary
Western Drug Inc. is recalling four containers of Dexpanthanol B5 250mg/mL Injection. The recall was initiated because the product lacks assurance of sterility. The affected product is a prescription injection manufactured by Western Drug Inc. in Springerville, Arizona.
The recall includes all lots of the product. Distribution was nationwide, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The source text does not specify the exact dates of distribution or the specific facilities where the product was sold.
Consumers and healthcare providers should stop using the recalled product and contact Western Drug Inc. for further instructions or a refund. The source text does not report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4
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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