The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1533-2015·Announced 2015-09-23

HCG Injection Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling HCG 500 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are classified as Severe (Score 4), particularly when structural or quality defects like GMP violations are present.

Plain-English summary

The Compounding Pharmacy of America is recalling HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall is due to a lack of assurance of sterility, as FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.

The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring between May 26, 2015, and July 10, 2015.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Manufacturer
The Compounding Pharmacy of America
Category
Drug — Injectable
Hazard

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 (16)

  • All lots distributed between November 2014 and May 2015
  • 04092015@59
  • 6/8/2015
  • 04162015@28
  • 6/15/2015
  • 03272015@2
  • 5/26/2015
  • 03302015@34
  • 5/29/2015
  • 04062015@71
  • 6/5/2015
  • 04162015@54
  • 05012015@36
  • 6/30/2015
  • 05112015@5
  • 7/10/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

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