The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0410-2016·Announced 2015-12-09

Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Concerns

Western Drug is recalling Hydroxocobalamin 5000IU/mL Injection because the product lacks assurance of sterility. The recall covers two 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, which corresponds to a Severe rating under the rubric. The hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Western Drug Inc. is recalling Hydroxocobalamin 5000IU/mL Injection, a prescription medication. The recall was initiated because the product lacks assurance of sterility. This defect means the manufacturer cannot guarantee that the injection is free from microbial contamination.

The recall involves two containers of the product. The affected items were 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 the product.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. Patients should not administer the recalled injection until further notice.

The recalled product

Product
Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable
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

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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