The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0426-2016·Announced 2015-12-09

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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.

See all 91 products in this recall →

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