Medaus Recalls Thiamine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Thiamine 100 mg/mL vials because the company cannot assure the sterility of the product. The recall covers lots 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.
Plain-English summary
Medaus, Inc. is recalling Thiamine 100 mg/mL, 2 mL vials due to a lack of assurance of sterility. The recall involves Lot # 151210-17 with a beyond-use date of 06/07/16. The product was distributed in the United States, Japan, and New Zealand.
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, or where the probability of serious adverse health consequences is remote.
Healthcare providers and consumers should stop using the affected product and contact Medaus, Inc. for further instructions or a replacement.
The recalled product
- Product
- THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable
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 #: 151210-17
- BUD: 06/07/16
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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