Medaus Recalls Manganese Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling Manganese Chloride 0.1mg/mL vials because the company cannot guarantee 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a pharmaceutical product, which aligns with the 'Severe' criteria for significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
Medaus, Inc. is recalling Manganese Chloride 0.1mg/mL PF, 10mL vials. The recall was initiated because the manufacturer lacks assurance of the product's sterility.
The affected product is identified by Lot # 151214-64 and has a best-use date of 5/31/16. The recall covers 1000 mL in vials. Distribution was reported in the U.S. Nationwide, Japan, and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- MANGANESE CHL 0.1MG/ML PF, 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 (2)
- Lot #: 151214-64
- BUD: 5/31/16
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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