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.
What this means for you
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.
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