Injectable Testosterone Recalled Due to Lack of Sterility Assurance
Drug Depot's testosterone injection product was recalled nationwide for lack of sterility assurance. Affected consumers should discontinue use and consult their healthcare provider.
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 for lack of sterility assurance in injectable medication. No reported illnesses or injuries. Per rubric, theoretical risk-of-harm to injectable product users without reported injury warrants High (3) severity.
Plain-English summary
Drug Depot, Inc., doing business as APS Pharmacy, is recalling its Testosterone Cypionate/Propionate Oil injectable medication due to lack of sterility assurance. The product is a 10 mL multi-dose vial containing 160 mg/mL cypionate and 20 mg/mL propionate (Formula ID 115498, Lot 759312).
The recall affects product distributed nationwide in the United States, including Puerto Rico. The best-use date for the recalled lot is August 30, 2022.
Lack of sterility assurance in injectable medications poses a potential contamination risk. No illnesses or injuries have been reported to date in connection with this recall.
Consumers who have this product should discontinue use immediately and consult with their healthcare provider about alternative treatment options.
The recalled product
- Product
- TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy
- Manufacturer
- Drug Depot, Inc., dba APS Pharmacy
- Category
- Drug — Injectable
- Hazard
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:759312 BUD: 8/30/2022
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.
See all 8 products in this recall →Related recalls
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- High