The Recall Desk
HighFDA (Drugs)·D-0731-2022·Announced 2022-04-06

Testosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance Defect

APS Pharmacy is recalling 73 vials of Testosterone Cypionate/Anastrozole oil due to lack of sterility assurance. The product was distributed nationwide including 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: FDA Class II recall of an injectable drug with a manufacturing sterility defect. Although no illnesses or injuries have been reported, injectables are inherently high-risk, and lack of sterility assurance poses a genuine contamination risk.

Plain-English summary

APS Pharmacy is recalling Testosterone Cypionate/Anastrozole *GS* Oil (200mg/0.5mg per mL) in multi-dose 10mL vials due to lack of sterility assurance in the manufacturing process.

The recalled product includes Lot 750851 (Formula ID 136164, 4mL, BUD 7/18/2022) and Lot 754549 (Formula ID 115962, 10mL, BUD 8/2/2022). A total of 73 vials were distributed nationwide in the USA, including Puerto Rico.

Patients or healthcare providers who have this product should contact their pharmacy or healthcare provider for guidance on replacement medication. Do not use this product.

The recalled product

Product
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar
Manufacturer
Drug Depot, Inc., dba APS Pharmacy
Category
Drug — Injectable hormone therapy
Hazard
  • sterility-defect
  • contamination-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)750851 BUD: 7/18/2022
  • b) 754549 BUD: 8/2/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category