FDAClass IISeptember 18, 2013

Testosterone Hypoallergenic 200 Mg/ml Injectable and recall: Sterility Concern

TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY…

Why was Testosterone Hypoallergenic 200 Mg/ml Injectable and recalled?

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted 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?

03112013@9, 05242013@17, 05312013@7, 06052013@21

Product
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY…
Recalling firm
Beacon Hill Medical Pharmacy, P.C.
Quantity
N/A
Distribution
USA nationwide
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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