The Recall Desk
SevereFDA (Drugs)·D-1245-2016·Announced 2016-07-20

Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious health consequences.

Plain-English summary

Medaus, Inc. is recalling Testosterone Cypionate 50 mg/mL with preservative (Benzyl Ethyl Alcohol 2%) in 1 mL, 2 mL, 3 mL, 4 mL, and 5 mL vials. The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is identified by Lot # 160119-12 with an expiration date of 07/17/16.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a replacement.

The recalled product

Product
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Steroid
Hazard

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 (6)

  • a) Lot #: 160119-12
  • BUD: 07/17/16. b) Lot #: 160119-12
  • BUD: 07/17/16. c) Lot #: 160119-12
  • BUD: 07/17/16. d) Lot #: 160119-12
  • BUD: 07/17/16. e) Lot #: 160119-12
  • BUD: 07/17/16.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 88 recalled by Medaus, 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 88 products in this recall →

Related recalls

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Same hazard · sterility

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