Thymosin Alpha Vials Recalled for Sterility Assurance Concerns
Advanced Nutriceuticals, LLC is recalling Thymosin Alpha vials because production processes cannot assure sterility. The product was distributed in seven states.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.
Plain-English summary
Advanced Nutriceuticals, LLC is recalling specific vials of Thymosin Alpha, 2000 mcg/ml, 5 ml. The recall is due to concerns with production processes that cannot assure the sterility of products intended to be sterile.
The affected product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. Specific lot numbers and expiration dates are listed in the official recall documentation.
Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Manufacturer
- Advanced Nutriceuticals, LLC
- Category
- Drug — Biological Product
- Hazard
- Affected units
- 4
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 (7)
- Lot #110220200
- 1102202009
- Exp 12/09/2020
- Lot #1105202009
- Exp 12/20/2020
- Lot #1110202008
- Exp 12/10/2020
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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