The Recall Desk
SevereFDA (Drugs)·D-1155-2019·Announced 2019-04-24

FDA Recalls HCG 40 Day Injection Vials for Sterility Concerns

Anderson Compounding Pharmacy is recalling HCG 40 Day Injection Extra Strength 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, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of infection associated with lack of sterility assurance in injectable drugs.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for HCG 40 Day Injection Extra Strength vials manufactured by Anderson Compounding Pharmacy, Inc. The recall covers all lots of the product, which is distributed nationwide. The product is identified as 2 vials per unit.

The reason for the recall is a lack of sterility assurance. This classification indicates that the product may not meet the required standards for being free from harmful microorganisms.

Consumers who have purchased this 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 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Affected units
2

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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