New Vitalis Pharmacy Recalls Testosterone Injection Due to Sterility Concerns
New Vitalis Pharmacy is recalling Testosterone Cypionate and Propionate oil injection solutions due to a lack of 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 infection or serious injury.
Plain-English summary
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy is recalling Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial. The recall was initiated because of a lack of sterility assurance in the product.
The affected product was distributed nationwide in the USA. The total quantity involved is 2981.62 mL. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between September 23, 2019, and November 3, 2019.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
- Category
- Drug — Injectable Steroid
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: AL-07232019@99
- exp 9-23-2019
- AL-07312019@99
- exp 9-30-2019
- AL-08132019@99
- exp 10-13-2019
- AL-08272019@901
- exp 10-27-2019
- AL-08282019@909
- exp 10-28-2019
- Al-09032019@903
- exp 11-3-2019
Distribution
Distributed nationwide across the United States.
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