The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1167-2016·Announced 2016-07-20

Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns

Medaus, Inc. is recalling B-Complex #3 vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the agency's Class II classification for a sterility issue in an injectable product warrants a Severe rating under the provided criteria for significant risk.

Plain-English summary

Medaus, Inc. is recalling B-Complex #3 (PF) 2 mL vials due to a lack of assurance of sterility. The affected product contains B1, B2, B3, B5, and B6 vitamins. The specific lot number is 151228-28, with a best-use date of 06/25/16.

The recall covers 1,000 mL in vials 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.

Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund.

The recalled product

Product
B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Vitamins
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 (2)

  • Lot #: 151228-28
  • BUD: 06/25/16

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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