The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0411-2016·Announced 2015-12-09

Western Drug Recalls M-Cobalamin Injections Due to Sterility Concerns

Western Drug is recalling M-Cobalamin (B12) injections because the FDA determined there is a lack of assurance of sterility. The recall affects 3 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 for significant injury or property damage reports, or high-risk contamination without reported fatalities.

Plain-English summary

Western Drug Inc. is recalling M-Cobalamin (B12) Injection 200 mcg and 2000mcg products. The recall was initiated because the FDA determined there is a lack of assurance of sterility for these products.

The recall involves 3 containers of the medication. These products were distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. All lots of the product are affected.

Consumers and healthcare providers should stop using the recalled M-Cobalamin injections and contact their healthcare provider for further instructions or alternative treatment options.

The recalled product

Product
M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injection
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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