The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0446-2016·Announced 2015-12-09

Western Drug Recalls Pyridoxine B6 Injections Due to Sterility Concerns

Western Drug is recalling Pyridoxine B6 100mg injections because the company cannot ensure the product is sterile. The recall covers three containers 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, an FDA Class II recall involving a risk of harm (lack of sterility in an injectable drug) where injury has not yet been reported but the hazard is significant falls under the 'Severe' category (Score 4), as it is not a Class I (Critical) but involves a serious potential health risk.

Plain-English summary

Western Drug Inc. is recalling three containers of Pyridoxine B6 100mg Inj, Rx. The recall was initiated because the company lacks assurance of the sterility of the product.

The affected product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall applies to all lots of this specific product.

Consumers and healthcare providers should stop using the recalled product and contact Western Drug Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable Medication
Hazard
Affected units
3

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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