The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1419-2014·Announced 2014-07-09

FDA Recalls HCG Tablets Compounded With Incorrect Solvent

FDA is recalling HCG 125U/Tab Tablet Tritu compounded by MD Custom Rx due to the use of an incorrect solvent.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 indicates a situation where use of the 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 rather than a high-risk pathogen or structural defect.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling HCG 125U/Tab Tablet Tritu, a prescription-only medication compounded by Brookfield Prescription Center Inc. dba MD Custom Rx. The recall involves 850 tablets distributed in Wisconsin.

The recall was initiated because specific drug products were compounded with an incorrect solvent, which is classified as an incorrect or undeclared excipient. The agency has classified this recall as Class II.

Consumers who have purchased these tablets should stop using them and contact their healthcare provider or pharmacist for further instructions. The affected lots have specific beyond-use dates ranging from June 2014 to July 2014.

The recalled product

Product
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Manufacturer
Brookfield Prescription Center Inc. dba MD Custom Rx
Category
Drug — Compounded Prescription
Hazard
Affected units
850

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 (17)

  • Lot # / Beyond Use Date: 05022014@5 / BUD 07/01/14
  • 04032014@7 / BUD 06/02/14
  • 04092014@16 / BUD06/08/14
  • 04142014@51 / BUD 06-13-14
  • 04152014@48 / BUD 06/14/14
  • 04172014@42 / BUD 06-06-14
  • 04182014@45 / BUD 6-17-14
  • 05162014@41 / BUD 07/15/14
  • 04172014@44 / BUD 06/16/14
  • 04212014@37 / BUD 6/20/14
  • 04222014@10 / BUD 06/21/14
  • 04232014@30 / BUD 06/22/14
  • 05072014@37 / BUD 07-06-14
  • 04292014@31 / BUD 06/28/14
  • 04302014@9 / BUD 06/29/14
  • 04252014@43 / BUD 06/24/14
  • 04222014@28 / BUD 6 -21-14

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 →

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