Innoveix Recalls Lyophilized Sermorelin Injection Due to Sterility Concerns
Innoveix Pharmaceuticals is recalling 1,747 vials of compounded Sermorelin injection because the product lacks sterility assurance.
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 and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Innoveix Pharmaceuticals Inc is recalling 1,747 vials of Lyophilized Sermorelin w/ GHRP2 3 mg For injection. The recall is being conducted because the product lacks sterility assurance. The affected lots are SER 925, SER 930, SER 935, SER 400, SER 405, and SER 410, with expiration dates ranging from November 2019 to July 2020.
The product was distributed nationwide within the United States. It is a prescription-only compounded medication. The source text does not specify the number of patients affected or report any specific illnesses or injuries.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Manufacturer
- Innoveix Pharmaceuticals Inc
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,747
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)
- Lots: SER 925 Exp. 11/4/19
- SER 930 Exp. 11/18/19
- SER 935 Exp. 2/21/20
- SER 400 Exp. 4/1/20
- SER 405 Exp. 5/11/20
- SER 410 Exp. 7/15/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Innoveix Pharmaceuticals 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 4 products in this recall →Related recalls
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