The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1226-2016·Announced 2016-07-20

Medaus Recalls Minoxidil Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling specific lots of Minoxidil 0.5% vials because the company cannot ensure the product is sterile.

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, which corresponds to a Severe rating under the rubric for significant injury or property damage risks, such as sterility failures in injectable or sterile-required products.

Plain-English summary

Medaus, Inc. is recalling 21,000 mL of Minoxidil 0.5% W/PRES. (Benzyl EtOH 2%) 10 mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The specific lots involved are 151130-64 (expiration date 05/28/16), 151228-22 (expiration date 06/25/16), and 160210-29 (expiration date 08/08/16).

Consumers who have these specific lots of Minoxidil vials should stop using them and contact Medaus, Inc. or their healthcare provider for further instructions.

The recalled product

Product
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Sterile 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 (6)

  • Lot #: 151130-64
  • BUD: 05/28/16
  • Lot #: 151228-22
  • BUD: 06/25/16
  • Lot #: 160210-29
  • BUD: 08/08/16

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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