Compounded Lyophilized AOD-9604 Injection Recalled for Sterility Risk
Innoveix Pharmaceuticals is recalling compounded lyophilized AOD-9604 3 mg injection vials nationwide due to lack of assurance of sterility. The affected product was distributed as Rx-only injectable medication.
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: This is an FDA Class II recall involving a compounded injectable drug with a sterility assurance failure, which poses a direct risk of serious infection if contaminated product was administered. Class II recalls with risk of serious health consequences map to Severe (score 4) per the rubric.
Plain-English summary
Innoveix Pharmaceuticals Inc is recalling 1,316 vials of compounded lyophilized AOD-9604, 3 mg, for subcutaneous or intramuscular injection nationwide. The recall is due to lack of assurance of sterility.
The affected product was compounded by Innoveix in Addison, TX and distributed for use as an Rx-only injectable medication. Four lots are affected: AOD205 (expiration 11/09/2021), AOD210 (expiration 11/18/2021), AOD215 (expiration 12/15/2021), and AOD220 (expiration 01/20/2022).
Consumers who have received this product should consult their healthcare provider. The FDA classifies this as a Class II recall.
The recalled product
- Product
- Compounded Lyophilized AOD-9604, 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
- lack-of-sterility
- contamination-risk
- injection-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 (4)
- Lot #: AOD205 Exp. 11/09/2021
- AOD210 Exp. 11/18/2021
- AOD215 Exp. 12/15/2021
- AOD220 Exp. 01/20/2022.
Distribution
Distributed nationwide across the United States.
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