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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 73
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
Part of a larger recall action
This product is one of 8 recalled by Drug Depot, Inc., dba APS Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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