The Recall Desk
SevereFDA (Drugs)·D-1151-2019·Announced 2019-04-24

Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

Anderson Compounding Pharmacy is recalling 99 vials of HCG 20 Day Extra Strength 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe; while specific injury reports are not detailed in the source, the lack of sterility assurance in an injectable drug represents a significant risk of harm consistent with the Severe tier for Class II drug recalls.

Plain-English summary

Anderson Compounding Pharmacy, Inc. is recalling 99 vials of HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial. The product was distributed nationwide. The recall was initiated because of a lack of sterility assurance.

The recalled product is identified as HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, manufactured by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, located at 310 Bluff City Hwy, Bristol, TN. The recall covers all lots of this specific product.

Consumers who possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Affected units
99

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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