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.
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, 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.
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