Medaus Recalls Manganese Sulfate Vials Due to Sterility Concerns
Medaus, Inc. is recalling Manganese Sulfate vials because the company cannot guarantee the product is sterile. The recall covers 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility assurance) corresponds to a score of 4 (Severe).
Plain-English summary
Medaus, Inc. is recalling Manganese Sulfate 0.1mg/mL (PF) in 2mL and 10mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected lots include 160115-24 and 160302-61, with expiration dates of July 13, 2016, and August 29, 2016, respectively.
The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 3,000 mL in vials.
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 that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Medication
- 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 (5)
- a) Lot #: 160115-24
- BUD: 07/13/16
- Lot #: 160302-61
- BUD: 08/29/16. b) Lot #: 160115-24
- BUD: 08/29/16.
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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