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.
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' 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
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.
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