The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1242-2016·Announced 2016-07-20

Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe (4). While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious adverse health consequences (infection/sepsis), aligning with the Severe criteria for Class II recalls where the hazard is significant.

Plain-English summary

Medaus, Inc. is recalling specific lots of Testosterone Cypionate 200 mg/mL with preservative (benzyl alcohol 2%) in 1 mL, 2 mL, 3 mL, 4 mL, and 5 mL vials. The recall was initiated due to a lack of assurance of sterility for the affected product.

The affected product was distributed nationwide in the United States, as well as in Japan and New Zealand. The recall includes approximately 8,000 mL of product in vials. Specific lot numbers and expiration dates are listed in the structured product information provided by the FDA.

Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, 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 (19)

  • a) Lot #151210-5
  • BUD: 06/07/16
  • Lot #160204-31
  • BUD: 08/02/16
  • Lot #160107-8
  • BUD: 07/05/16
  • Lot #160303-47
  • BUD: 08/30/16. b) Lot #151210-5
  • BUD: 08/30/16. c) Lot #151207-8
  • BUD: 06/04/16
  • BUD: 08/30/16
  • Lot #151210-5
  • Lot #160106-34
  • BUD: 07/04/16
  • Lot#160208-22
  • BUD: 08/06/16. d) Lot #151210-5
  • BUD: 08/30/16. e) Lot #151210-5
  • BUD: 08/02/16
  • BUD: 08/30/16.

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 →

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