FDA Recalls Vitamin D3 Injection Due to Sterility Assurance Concerns
Anderson Compounding Pharmacy is recalling Vitamin D3 200,000 IU/mL Injection vials nationwide due to a lack of sterility assurance.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential health consequences like sterility issues in injectable products, even without reported hospitalizations in the text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Vitamin D3 200,000 IU/mL Injection, 2 mL Vials, manufactured by Anderson Compounding Pharmacy, Inc. The recall covers all lots of the product, with a total quantity of 4 vials affected. The product was distributed nationwide.
The recall was initiated due to a lack of sterility assurance. The source text does not specify the exact nature of the sterility failure or report any specific illnesses or injuries associated with the product.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies 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 D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4
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.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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