FDA Recalls HCG 20,000 Units Vials Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling HCG 20,000 units/vial products nationwide due to a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 severity score under the rubric for significant injury or health risk potential.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for HCG 20,000 units/vial products manufactured by Anderson Compounding Pharmacy, Inc. The recall covers all lots of the product, which is distributed nationwide.
The recall was initiated due to a lack of sterility assurance. This classification indicates that the product may not meet the required standards for being free of microorganisms, which could pose a risk to patients using the medication.
Consumers who have purchased or been prescribed this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 1
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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