The Recall Desk
HighFDA (Drugs)·D-0732-2022·Announced 2022-04-06

Testosterone Cypionate Injectable Recalled Due to Lack of Sterility Assurance

Drug Depot, Inc. is recalling 620 vials of Testosterone Cypionate/DHEA injectables due to lack of sterility assurance in manufacturing. The product was distributed nationwide.

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 is an FDA Class II recall of an injectable product with a lack of sterility assurance, which constitutes a risk-of-harm product. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Drug Depot, Inc., doing business as APS Pharmacy, is recalling 620 vials of Testosterone Cypionate/DHEA 200/10 mg/mL Injectable due to lack of sterility assurance. The recalled product consists of multi-dose 10 mL vials available in two formulations: Formula ID 115678 (Lot 746000, use-by date 6/26/2022) and Formula ID 115498 (Lot 751472, use-by date 7/20/2022).

The affected product was distributed nationwide in the United States, including Puerto Rico. Lack of sterility assurance means the manufacturing process did not ensure the product is free from microbial contamination, which could pose a risk of serious infection to users who receive injections from these vials.

If you have this product, do not use it. Consult your healthcare provider or pharmacist for guidance on safe disposal and obtaining a replacement. Report any adverse health effects to the FDA's MedWatch program at 1-888-SAFEFDA.

The recalled product

Product
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
Manufacturer
Drug Depot, Inc., dba APS Pharmacy
Category
Drug — Injectable / Testosterone
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 (2)

  • Lots: a)746000 BUD: 6/26/2022
  • b) 751472 BUD: 7/20/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category