The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1168-2016·Announced 2016-07-20

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

Medaus, Inc. is recalling B-Complex #3 vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

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 source text identifies the agency classification as Class II. Per the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product is classified as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Medaus, Inc. is recalling specific lots of B-Complex #3 W/PRES (Benzyl Ethol 2%) 10mL vials. The recall is being conducted because of a lack of assurance of sterility in the product. The affected product contains B1, B2, B3, B5, and B6 vitamins.

The recalled product was distributed in the United States, Japan, and New Zealand. The specific lots affected are 160115-3, 160202-10, 160204-43, 160223-3, 160307-26, and 160309-1, all with a best-use date of 06/11/16. The total quantity involved is 380 mL in vials.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Vitamin
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)

  • Lot #: 160115-3
  • BUD: 06/11/16
  • Lot #: 160202-10
  • Lot #: 160204-43
  • Lot #: 160223-3
  • Lot #: 160307-26
  • Lot #: 160309-1

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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