The Recall Desk
ModerateFDA (Drugs)·D-0989-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls 1-HCG 2000 IU/ML Vials

Well Care Compounding Pharmacy is recalling 1-HCG 2000 IU/ML vials due to GMP violations that may affect sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of 1-HCG 2000 IU/ML, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The specific lot number is 032520164, with an expiration date of 06/23/2016.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Affected units
869

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 (2)

  • Lot #: 032520164: 7@1
  • Exp 06/23/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care 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 51 products in this recall →