The Recall Desk
SevereFDA (Drugs)·D-1230-2016·Announced 2016-07-20

Medaus Recalls Nandrolone Decanoate Vials Due to Sterility Concerns

Medaus, Inc. is recalling Nandrolone Decanoate 200mg/mL vials because the company cannot guarantee 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Medaus, Inc. is recalling Nandrolone Decanoate 200mg/mL with Benzyl Alcohol 10% preservative in 2mL, 4mL, and 5mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is identified by Lot # 160203-18 with a beyond-use date of 08/01/16.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 400 mL in vials.

Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a return. This recall is classified as Class II by the FDA.

The recalled product

Product
NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.

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 (4)

  • a) Lot #: 160203-18
  • BUD: 08/01/16. b) Lot #: 160203-18
  • BUD: 08/01/16. c) Lot #: 160203-18
  • BUD: 08/01/16.

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 →