Agency classClass IIOur severity:High FDA (Drugs)·D-1233-2022·Announced 2022-07-20

Compounded Testosterone/Anastrozole Injectable Vials Recalled for Sterility Assurance

Tailor Made Compounding is recalling 106 vials of compounded testosterone/anastrozole injectable due to lack of sterility assurance. The product was 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 a Class II FDA recall of an injectable drug with no reported illnesses or injuries documented. The lack of sterility assurance in a compounded injectable represents a significant potential risk to patient safety, as injectable drugs require strict sterility standards to prevent serious infections and complications.

Plain-English summary

Tailor Made Compounding is recalling 106 vials of a compounded injectable containing Testosterone Cypionate 200 mg/mL and Anastrozole 1 mg/mL. The product is supplied in both 4 mL and 10 mL vials.

The recall was issued due to lack of assurance of sterility. The manufacturer cannot confirm that the product was manufactured under conditions ensuring it is free from bacterial and fungal contamination, which is a critical requirement for injectable medications.

The affected product was distributed nationwide in the United States and Puerto Rico. Multiple batch numbers are involved with expiration dates in 2022.

Patients who received this medication should consult their healthcare provider regarding the recalled product and appropriate alternative treatment options.

The recalled product

Product: Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Compounded Injectable
Hazard: sterility-failure
contamination-risk
Affected units: 106

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 (10)

Batch#: a)10142123A2
Exp 4/12/2022
02042202A1
Exp 8/3/2022
b) 10142121A2
10202105A1
Exp 4/18/2022
11102102A1
Exp 4/30/2022
Exp 8/3/2022.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

See all →

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FDA (Drugs) · 2022-07-20
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Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
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Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20

Same hazard · sterility failure