FDA Recalls Testosterone Cypionate/Anastrozole from Tailor Made Compounding Due to Sterility Concerns
Tailor Made Compounding recalls 41 vials of Testosterone Cypionate/Anastrozole due to lack of assured sterility. FDA Class II recall affects products distributed nationwide.
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 without reported illnesses or injuries. Lack of sterility assurance poses a theoretical risk of infection; however, no actual contamination or patient harm is reported, so the score is limited to 3 per the rubric guidance on theoretical hazards without reported illness.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 41 vials of Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL in 10mL vials because the manufacturer cannot assure the product maintains sterility during storage at room temperature.
The affected batches are: 11232117A1 (Expiration 5/22/2022) and 01312215A1 (Expiration 7/30/2022). The product was distributed nationwide in the United States and Puerto Rico.
Lack of sterility assurance in injectable medications poses a risk of infection if contaminated product is administered. Patients who have received this product should consult their healthcare provider if they experience signs of infection at the injection site or systemic symptoms.
Consumers in possession of the recalled product should stop use and contact their healthcare provider or pharmacist for guidance. Do not discard medication in the trash or flush down the toilet; return it to a pharmacy for proper disposal.
The recalled product
- Product
- Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Affected units
- 41
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#: 11232117A1
- Exp 5/22/2022
- 01312215A1
- 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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