The Recall Desk
SevereFDA (Drugs)·D-0523-2020·Announced 2019-12-04

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.

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 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

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.

Same manufacturer · New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

See all →