The Recall Desk
SevereFDA (Drugs)·D-1164-2018·Announced 2018-09-05

Auro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns

Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Auro Pharmacies, Inc. is recalling 32 vials of Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in 5 mL and 8 mL multiple-dose vials. The product was distributed nationwide in the USA. The specific lot number is 180606/18, with an expiration date of 30-Nov-18.

The recall was initiated due to a lack of assurance of sterility. The source text states that inadequate processes and equipment were used to assure the sterility of products intended to be sterile.

Consumers and healthcare providers should stop using the affected product and contact Auro Pharmacies, Inc. or their healthcare provider for further instructions.

The recalled product

Product
Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Manufacturer
Auro Pharmacies, Inc.
Category
Drug — Injectable Sterile Product
Hazard
Affected units
32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 180606/18
  • Exp 30-Nov-18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Auro Pharmacies, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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Same manufacturer · Auro Pharmacies, Inc.

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Same hazard · sterility failure

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