FDAClass IISeptember 18, 2013

Testosterone Cypionate recall: Sterility Concern

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

Why was Testosterone Cypionate recalled?

Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.

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 #05072013@1, Exp 11/3/2013

Product
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
Recalling firm
South Coast Specialty Compounding, Inc.
Quantity
117 vials
Distribution
CA, IN
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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