Testosterone Propionate Injectable Vials Recalled Over Sterility Assurance
Testosterone propionate injectable vials are being recalled due to lack of assurance of sterility. The recall affects product distributed nationwide in the USA and 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: This is an injectable pharmaceutical product where the lack of sterility assurance presents a significant health risk. Per the severity rubric, this qualifies as a risk-of-harm product where no injuries have been reported, resulting in a High severity score.
Plain-English summary
Tailor Made Compounding is recalling testosterone propionate 100mg/ml injectable vials due to a lack of assurance of sterility. The affected product includes 64 vials with the following batch numbers and expiration dates: Batch 12012123A2 (expires 5/30/2022) and Batch 01312212A1 (expires 7/30/2022).
The product was distributed nationwide throughout the United States and Puerto Rico.
Patients who received this product should contact their healthcare provider immediately. Do not use the product. Return unused product to the pharmacy or healthcare facility where it was obtained.
The recalled product
- Product
- Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Affected units
- 64
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)
- Batch#: 12012123A2
- Exp 5/30/2022
- 01312212A1
- Exp 7/30/2022.
Distribution
Part of a larger recall action
This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding 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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