Compounded Semorelin/Ipamorelin Injection Recalled for Sterility Assurance
Innoveix Pharmaceuticals is recalling 728 vials of compounded Semorelin/Ipamorelin 3 mg injection due to lack of assurance of sterility. The affected lots are SIP215, SIP220, and SIP210.
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 FDA classified this as a Class II recall. Lack of assurance of sterility in a compounded injectable product is a serious hazard because injectable drugs bypass the body's natural defensive barriers; contamination can lead to infection, sepsis, or serious systemic complications. Although no illness reports are stated in the source text, the hazard itself—sterility assurance failure in an injectable—is inherently high-risk and justifies a Severe rating under Class II criteria.
Plain-English summary
Innoveix Pharmaceuticals Inc is recalling compounded Lyophilized Semorelin/Ipamorelin 3 mg for subcutaneous or intramuscular injection due to lack of assurance of sterility. A total of 728 vials have been distributed nationwide within the United States.
The recall affects three lots: SIP215 (Exp. 01/14/2022), SIP220 (Exp. 01/23/2022), and SIP210 (Exp. 12/15/2021). The product is prescription-only and was compounded by Innoveix in Addison, Texas.
Patients who have received this product should contact their healthcare provider or pharmacy to determine if they have received an affected lot. Healthcare providers and patients should not use recalled vials and should contact Innoveix Pharmaceuticals at 800-370-1910 for further guidance.
The recalled product
- Product
- Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Manufacturer
- Innoveix Pharmaceuticals Inc
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance-failure
- contamination-risk
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 (3)
- Lot #: SIP215 Exp. 01/14/2022
- SIP220 Exp. 01/23/2022
- SIP210 Exp. 12/15/2021
Distribution
Distributed nationwide across the United States.
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