Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling HCG 11,000 mcg Injection vials 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the snippet, the lack of sterility assurance in an injectable drug is a significant safety hazard that aligns with the Severe criteria for Class II recalls involving potential serious harm.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling HCG 11,000 mcg Injection, 30 mL Vials. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product is distributed nationwide. The recall covers all lots of the HCG 11,000 mcg Injection, 30 mL Vial manufactured by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, located at 310 Bluff City Hwy, Bristol, TN.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable
- Hazard
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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