The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1223-2016·Announced 2016-07-20

Medaus Recalls M.I.C B-Complex Vials Due to Sterility Concerns

Medaus, Inc. is recalling M.I.C B-Complex 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral product, which poses a significant risk of infection or serious injury.

Plain-English summary

Medaus, Inc. is recalling M.I.C B-Complex W/PRES. (Benzyl Ethoh 2%) 5 mL vials. The recall is due to a lack of assurance of sterility. The affected product contains B1, B2, B3, B5, B6, Cyanocobalamin, Choline Chloride, Inositol, and Methionine.

The recall covers 1,430 mL in vials distributed in the United States, Japan, and New Zealand. Specific lot numbers and expiration dates are listed in the official recall notice.

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

The recalled product

Product
M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Parenteral
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 (12)

  • Lot #: 160119-59
  • BUD: 05/26/16
  • Lot #: 151228-72
  • Lot #: 160127-4
  • Lot #: 160201-13
  • Lot #: 160202-13
  • Lot #: 160204-11
  • Lot #: 160202-66
  • BUD: 06/11/16
  • Lot #: 160307-31
  • Lot #: 160224-68
  • Lot #: 160205-8

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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