Medaus Recalls B-Complex Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials because the company cannot ensure the product is sterile.
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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable product represents a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials containing preservatives. The recall is being conducted because the manufacturer lacks assurance that the product is sterile. The affected product is available in 2 mL, 5 mL, and 10 mL vials.
The recall covers specific lots with expiration dates of May 28, 2016. The affected lots include 160209-24, 160106-12, 160222-70, 160129-9, and 160202-16. The product was distributed in the United States, Japan, and New Zealand.
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 as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 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 (7)
- a) Lot #: 160209-24
- BUD: 05/28/16. b) Lot #: 160106-12
- BUD: 05/28/16
- Lot #: 160222-70
- BUD: 05/28/16. c) Lot #: 160129-9
- Lot #: 160202-16
- BUD: 05/28/16.
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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