FDAClass IISeptember 23, 2015

Testosterone Cypionate 50 mg/ml Injection recall: Sterility Concern

Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Why was Testosterone Cypionate 50 mg/ml Injection 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; 02022015@1, 8/1/2015

Product
Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Recalling firm
The Compounding Pharmacy of America
Quantity
12 ml
Distribution
Nationwide
Recall date
September 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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