The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1174-2016·Announced 2016-07-20

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.

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. 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.

See all 88 products in this recall →

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