The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-476-2013·Announced 2013-06-05

HCG Injection Recalled Due to Sterility Assurance Concerns

Nora Apothecary and Alternative Therapies, Inc. recalled HCG injection products because FDA inspection findings raised concerns about quality control and sterility assurance. The products were distributed nationwide.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a lack of assurance of sterility, which is a risk-of-harm issue. The source does not report an injury, so the High criterion applies.

Plain-English summary

The recall covers HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, from Nora Apothecary and Alternative Therapies, Inc. The product information lists a quantity of 3.

FDA inspection findings raised concerns about quality control processes and a lack of assurance of sterility. The distribution pattern is nationwide, and the code information includes all products within their expiration date, including those dated from Jan. 2013 through April 19, 2013.

The source text does not state what consumers should do with affected products.

The recalled product

Product
HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — HCG injection
Hazard
Affected units
3

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)

  • 2013 (Jan. 2013 to April 19
  • 2013).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 43 recalled by Nora Apothecary and Alternative Therapies, Inc. 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 43 products in this recall →

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