Western Drug Recalls Vitamin B12 Injections Due to Sterility Concerns
Western Drug is recalling Vitamin B12 injections because the company cannot ensure the product is sterile. The recall covers eight 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable drug) are classified as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Western Drug Inc. is recalling eight containers of Vitamin B12 (Cyan) Inj 100mcg/mL and 1000mcg/mL. The recall is being conducted 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 includes all lots of the product.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injectable Vitamin
- Affected units
- 8
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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