The Recall Desk
SevereFDA (Drugs)·D-1181-2016·Announced 2016-07-20

Medaus Recalls DMSO 99.9 Vials Due to Sterility Concerns

Medaus, Inc. is recalling DMSO 99.9 vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are present but the defect is structural/quality-related.

Plain-English summary

Medaus, Inc. is recalling DMSO 99.9 (PF) in 5 mL and 10 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product was distributed in the United States, Japan, and New Zealand.

The recall includes specific lots of 5 mL and 10 mL vials with expiration dates ranging from May 30, 2016, to September 5, 2016. The total quantity involved is 2,218 mL in vials. The source text does not report any illnesses or injuries associated with this recall.

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

The recalled product

Product
DMSO 99.9 (PF), In a) 5ML Vials and b) 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 (20)

  • a) Lot #: 151217-2
  • BUD: 05/30/16
  • Lot #: 160115-6
  • Lot #: 160303-8
  • BUD: 08/30/16
  • Lot #: 160303-10
  • BUD: 08/30/16. b) Lot #: 151203-37
  • Lot #: 151203-72
  • Lot #: 151209-7
  • Lot #: 151209-8
  • Lot #: 151209-9
  • Lot #: 151209-10
  • Lot #: 151209-11
  • Lot #: 151209-13
  • Lot #: 151209-14
  • Lot #: 160104-31
  • Lot #: 160113-77
  • Lot #: 151218-7
  • BUD: 06/15/16
  • Lot #: 151218-8

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 →

Related recalls

Same manufacturer · Medaus, Inc.

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Same hazard · lack of sterility

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