The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1180-2016·Announced 2016-07-20

Medaus Recalls DMPS 50mg/mL Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as infection from lack of sterility) are categorized as Severe (Score 4), particularly when structural or sterility defects are involved.

Plain-English summary

Medaus, Inc. is recalling DMPS 50mg/mL (PF), 5mL vials due to a lack of assurance of sterility. The recall involves Lot # 151216-33 with a beyond-use date of 06/13/16. The product was distributed in the U.S. nationwide, Japan, and New Zealand.

The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is the potential presence of non-sterile conditions in the vials, which could pose a risk of infection if administered to patients.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a refund. The recall number is D-1180-2016.

The recalled product

Product
DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Solution
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 #: 151216-33
  • BUD: 06/13/16

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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