FDAClass IISeptember 5, 2018

Testosterone Enanthate/Cypionate injectable recall: Sterility Concern

Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Why was Testosterone Enanthate/Cypionate injectable recalled?

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

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?

Lot #: 180709/24, Exp 07-Sep-18

Product
Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Recalling firm
Auro Pharmacies, Inc.
Quantity
11 vials
Distribution
Nationwide in USA
Recall date
September 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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