The Recall Desk
SevereFDA (Drugs)·D-1196-2019·Announced 2019-04-24

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.

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. 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.

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.

See all 68 products in this recall →

Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

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