Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling 57 vials of HCG 30 Day due to a lack of sterility assurance. The products were distributed nationwide.
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. Per the rubric, FDA Class II recalls with potential for serious injury (such as sterility failures in injectable drugs) are rated as Severe.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 57 vials of HCG 30 Day, 3750 Units/6 mL, 10 mL Vial. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product was distributed nationwide. The recall covers all lots of the medication.
Consumers who have this product should stop using it and contact Anderson Compounding Pharmacy at 1-800-263-8890 for further instructions.
The recalled product
- Product
- HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 57
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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