Advanced Nutriceuticals Recalls IPAMORELIN Vials Due to Sterility Concerns
Advanced Nutriceuticals is recalling IPAMORELIN vials because production processes cannot assure the sterility of the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a critical sterility failure for a sterile product, align with a Severe rating (Score 4).
Plain-English summary
Advanced Nutriceuticals, LLC is recalling IPAMORELIN, 2000 MCG/ML, 5 ML vials. The recall involves three vials distributed to The Guyer Institute of Molecular Medicine in Indianapolis, IN, as well as locations in California, Colorado, Florida, Kentucky, Ohio, and Texas.
The recall is being conducted due to a lack of assurance of sterility. The company identified concerns with production processes that cannot assure the sterility of products intended to be sterile.
Consumers and healthcare providers should stop using the affected IPAMORELIN vials and contact Advanced Nutriceuticals, LLC for further instructions.
The recalled product
- Product
- IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Manufacturer
- Advanced Nutriceuticals, LLC
- Category
- Drug — Injectable
- 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 (6)
- Lot # 1029202005
- Exp 11/29/2020
- Lot #1102202014
- Exp 12/08/2020
- Lot #1112202002
- Exp 12/12/2020
Distribution
Part of a larger recall action
This product is one of 17 recalled by Advanced Nutriceuticals, LLC 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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