The Recall Desk
ModerateFDA (Drugs)·D-1420-2014·Announced 2014-07-09

MD Custom Rx Recalls HCG Drops Due to Incorrect Solvent

MD Custom Rx is recalling HCG drops compounded with an incorrect solvent. The recall covers specific lots distributed in Wisconsin.

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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a compounding error (incorrect solvent) rather than a high-risk pathogen or structural defect.

Plain-English summary

Brookfield Prescription Center Inc. dba MD Custom Rx is recalling HCG (Human Chorionic Gonadotropin) 200 units/0.1 mL drops. The product is packaged in 5 mL and 10 mL bottles and is prescription-only. The recall is due to the use of an incorrect solvent during the compounding process.

The affected product was distributed only in Wisconsin. Specific lot numbers and beyond-use dates are listed in the recall notice, including lots with beyond-use dates ranging from June 15, 2014, to July 12, 2014.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045

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 (6)

  • Lot # / Beyond Use Date: 04232014@49 / BUD 06-22-14
  • 04232014@2 / BUD 06/22/14
  • 04252014@27 / BUD 06/24/14
  • 04162014@33 / BUD06/15/14
  • 05132014@2 / BUD 07/12/14
  • 05092014@39 BUD 7-8-14

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 6 recalled by Brookfield Prescription Center Inc. dba MD Custom Rx 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 6 products in this recall →

Same manufacturer · Brookfield Prescription Center Inc. dba MD Custom Rx

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