Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns
Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot assure the sterility of the product.
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. Under the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable products are categorized as Severe.
Plain-English summary
Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL (PF) in 2 mL and 5 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product.
The affected product includes Lot # 160126-20 with a beyond-use date of 07/24/16. The total quantity involved is 2,000 mL in vials. The product was distributed in the United States, Japan, and New Zealand.
Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML 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 (3)
- a) Lot #: 160126-20
- BUD: 07/24/16. b) Lot #: 160126-20
- BUD: 07/24/16.
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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