FDAClass IISeptember 23, 2015

Testosterone Tri-Blend 200 mg/ml recall: Sterility Concern

Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN

Why was Testosterone Tri-Blend 200 mg/ml recalled?

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots distributed between November 2014 and May 2015; 01122015@49, 7/11/2015

Product
Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN
Recalling firm
The Compounding Pharmacy of America
Quantity
15 ml total
Distribution
Nationwide
Recall date
September 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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