Epithalon injection recalled from one lot for lack of sterility assurance
GenoGenix is recalling Epithalon for Injection, 20mg, in all presentations from a single lot for lack of assurance of sterility.
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 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
Epithalon for Injection, 20mg, in all presentations, from GenoGenix, LLC of Boca Raton, Florida and manufactured for Extension Health, is being recalled for lack of assurance of sterility.
The recall covers lot GG053025-002 within expiry, distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Healthcare providers and patients holding the affected lot should stop using it and contact the firm or their prescriber.
The recalled product
- Product
- Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
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 (1)
- Lot#: GG053025-002 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 57 recalled by GenoGenix 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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