The Recall Desk
SevereFDA (Drugs)·D-1252-2016·Announced 2016-07-20

Medaus Recalls Arginine Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure the product is sterile.

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 sterility assurance for an injectable product, which poses a risk of serious injury or death, meeting the criteria for a Severe rating.

Plain-English summary

Medaus, Inc. is recalling Lot 151217-12 of Arginine 100mg/mL (PF), 10mL vials, with a best-use date of 06/14/16. The recall was initiated because the company lacks assurance of the sterility of the affected product.

The affected product was distributed in the United States, Japan, and New Zealand. The total quantity involved is 1,000 mL in vials.

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

The recalled product

Product
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable
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 (2)

  • Lot #: 151217-12
  • BUD: 06/14/16

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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