Western Drug Recalls HCG Injection Due to Sterility Assurance Concerns
Western Drug is recalling HCG 10,000U/10mL Injection because the product lacks assurance of sterility. The recall covers all lots 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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug is classified as Severe (Score 4), particularly given the potential for serious injury from non-sterile injections.
Plain-English summary
Western Drug Inc. is recalling HCG 10,000U/10mL Injection, a prescription medication. The recall is being conducted because the product lacks assurance of sterility. This issue affects all lots of the product.
The recalled product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall involves 8 containers of the medication.
Consumers and healthcare providers should stop using the recalled HCG 10,000U/10mL Injection and contact their healthcare provider for further instructions or to obtain a replacement if appropriate.
The recalled product
- Product
- HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona
- Manufacturer
- Western Drug
- Category
- Drug — Injectable
- Hazard
- 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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