The Recall Desk
HighFDA (Drugs)·D-0734-2022·Announced 2022-04-06

Testosterone Cypionate Injectable Vials Recalled for Lack of Sterility Assurance

Drug Depot, Inc. is recalling 24 vials of Testosterone Cypionate 200 MG/ML Injectable nationwide due to lack of sterility assurance. The product was distributed throughout the USA and Puerto Rico.

What this means for you

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: This FDA Class II recall involves a risk-of-harm product (non-sterile injectable medication) where no illnesses or injuries have been reported. The lack of sterility assurance on an injectable poses a serious theoretical risk of infection, meeting the rubric criterion for score 3.

Plain-English summary

Drug Depot, Inc., dba APS Pharmacy, is recalling Testosterone Cypionate *GS* Oil 200 MG/ML Injectable in multi-dose 10ML vials (Formula ID 76681). The recall affects 24 vials distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to lack of sterility assurance. Non-sterile injectable medications pose a risk of serious infection and other complications for users.

The affected product is identified by Lot 754381 with a beyond-use date of 8/1/2022. Consumers who have received this product should contact their healthcare provider or pharmacy immediately and should not use the recalled vials.

The recalled product

Product
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
Manufacturer
Drug Depot, Inc., dba APS Pharmacy
Hazard
  • lack-of-sterility
  • infection-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 (1)

  • Lot: 754381 BUD: 8/1/2022

Distribution

Distributed nationwide across the United States.