The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1227-2016·Announced 2016-07-20

Medaus Recalls Molybdenum Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Molybdenum 250mcg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution 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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a risk of harm (lack of sterility) without reported illness falls under the 'Severe' category (Score 4), as it is not a Class I recall but involves a significant potential for adverse health consequences.

Plain-English summary

Medaus, Inc. is recalling Molybdenum 250mcg/mL (PF), 10mL vials. The recall was initiated because the company lacks assurance of the sterility of the product. The affected product is identified by Lot # 151209-24 with a beyond-use date of 06/06/16.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. 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.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a return. No specific instructions for disposal or replacement are provided in the source text.

The recalled product

Product
MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Pharmaceutical
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 #: 151209-24
  • BUD: 06/06/16

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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