Medaus Recalls Selenium Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling specific lots of Selenium 200mcg/mL 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 potential serious, reversible health consequences.
Plain-English summary
Medaus, Inc. is recalling 884 mL of Selenium 200mcg/mL (PF) 10mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product.
The affected product was distributed nationwide in the United States, as well as in Japan and New Zealand. The recall covers 21 specific lots with expiration dates of May 21, 2016, or August 14, 2016.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable
- 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)
- Lot #: 151130-35
- BUD: 05/21/16
- Lot #: 151202-28
- Lot #: 151223-68
- Lot #: 151216-20
- Lot #: 151123-77
- Lot #: 151204-22
- Lot #: 160111-30
- Lot #: 160112-27
- Lot #: 160120-8
- Lot #: 160118-12
- Lot #: 160119-20
- Lot #: 160202-37
- Lot #: 160208-61
- Lot #: 160208-62
- Lot #: 160216-37
- BUD: 08/14/16
- Lot #: 160216-38
- Lot #: 160216-35
- Lot #: 160216-40
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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