The Recall Desk
SevereFDA (Drugs)·D-0471-2016·Announced 2015-12-09

Western Drug Recalls Hydroxocobalamin Injections Due to Sterility Concerns

Western Drug is recalling Hydroxocobalamin 1mg Injections because the company cannot guarantee the product is sterile.

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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Western Drug Inc. is recalling Hydroxocobalamin 1mg Injections. The recall was initiated because the company lacks assurance of the product's sterility. The affected product is a prescription medication distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.

The recall covers all lots of the product. The source text does not specify the exact number of units recalled or the specific dates of distribution. Consumers and healthcare providers should stop using the recalled injections and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
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 →