Testosterone Cypionate/Propionate Injection Recalled for Sterility Assurance
New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.
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 FDA has classified this as a Class II recall. Lack of sterility assurance in injectable medications poses a significant risk of serious infection and potential hospitalization. Class II recalls with injectable products involving sterility failures meet the threshold for Severe.
Plain-English summary
New Vitalis Pharmacy LLC is recalling Testosterone Cypionate/Testosterone Propionate (180mg/mL and 20mg/mL) injectable medication in 1 mL vials due to lack of assurance of sterility. The recalled product was distributed nationwide in the United States.
The recall involves six lots with expiration dates ranging from September 18, 2021 to October 23, 2021: Lot #AL07202021@901 (Exp 9/18/21), Lot #AL07272021@901 (Exp 9/25/21), Lot #AL08032021@901 (Exp 10/2/21), Lot #AL08102021@901 (Exp 10/9/21), Lot #AL08172021@901 (Exp 10/16/21), and Lot #AL08242021@901 (Exp 10/23/21). A total of 1,347 vials are affected.
Patients currently using this product should contact their healthcare provider or pharmacy immediately. Do not use any vials from the recalled lots. Consult with your healthcare provider about appropriate next steps and possible replacement therapy.
The recalled product
- Product
- Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
- Category
- Drug — Injectable Hormone
- Affected units
- 1,347
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 (13)
- Lot
- expiry: Lot #AL07202021@901
- Exp 9/18/21
- Lot #AL07272021@901
- Exp 9/25/21
- Lot #AL08032021@901
- Exp 10/2/21
- Lot #AL08102021@901
- Exp 10/9/21
- Lot #AL08172021@901
- Exp 10/16/21
- Lot #AL08242021@901
- Exp 10/23/21
Distribution
Distributed nationwide across the United States.
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