Medaus Recalls Thiamine Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling specific lots of Thiamine 100 mg/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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
Medaus, Inc. is recalling specific lots of Thiamine 100 mg/mL with preservative (benzalkonium 0.01%), 5 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.
The affected product was distributed in the United States, Japan, and New Zealand. The specific lots involved are 160129-2, 160201-10, 160222-19, 160215-12, and 160315-2, all with a best-use date of 06/07/16.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML 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 (6)
- Lot #: 160129-2
- BUD: 06/07/16
- Lot #: 160201-10
- Lot #: 160222-19
- Lot #: 160215-12
- Lot #: 160315-2
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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