Injectable testosterone-anastrozole mixture recalled for sterility assurance failure
Drug Depot (APS Pharmacy) is recalling testosterone cypionate/anastrozole injectable oil due to lack of sterility assurance. The recall affects 846 vials 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: FDA Class II recall of an injectable pharmaceutical product with no reported illnesses or injuries. The hazard—lack of sterility assurance—represents a significant risk of harm in a parenteral product, meeting the criterion for High severity.
Plain-English summary
Drug Depot, Inc., operating as APS Pharmacy, is recalling testosterone cypionate/anastrozole injectable oil in 10 mL multi-dose vials. The recall was initiated due to lack of sterility assurance in the manufacturing process.
The affected product contains 200 mg/mL testosterone cypionate and 1 mg/mL anastrozole. A total of 846 vials have been distributed nationwide, including Puerto Rico. Specific affected lots include: 745383 (BUD 6/20/2022), 759295 (BUD 8/30/2022), 745749 (BUD 6/21/2022), and 746272 (BUD 6/27/2022).
Non-sterile injectable products pose a risk of serious infection. Consumers who have received this product should contact their healthcare provider immediately if they experience signs of infection such as fever, redness, or swelling at the injection site.
The recalled product
- Product
- TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
- Manufacturer
- Drug Depot, Inc., dba APS Pharmacy
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- contamination-risk
- 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 (4)
- Lots: a) 745383 BUD: 6/20/2022
- 759295 BUD: 8/30/2022
- b) 745749 BUD: 6/21/2022
- 746272 BUD: 6/27/2022
Distribution
Distributed nationwide across the United States.
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