Western Drug Recalls Ascorbic Acid Injection Due to Sterility Concerns
Western Drug is recalling Ascorbic Acid 500 mg/mL Injection because the product lacks assurance of sterility. The recall covers six 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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Lack of sterility in an injectable drug is a significant risk that fits the 'Severe' criteria for Class II recalls with potential for serious harm.
Plain-English summary
Western Drug Inc. is recalling six containers of Ascorbic Acid 500 mg/mL Injection, a prescription medication. The recall was initiated because the product lacks assurance of sterility, which is a critical quality attribute for injectable drugs.
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 covers all lots of the product.
Healthcare providers and patients should stop using the recalled product and contact Western Drug Inc. or their local FDA office for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injectable
- Affected units
- 6
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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