The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1221-2016·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 (PF) vials because the company cannot assure the sterility of the product. The recall affects 3,000 mL in 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable product represents a significant potential hazard consistent with a Class II classification.

Plain-English summary

Medaus, Inc. is recalling M.I.C./B-Complex (PF) 2 mL vials due to a lack of assurance of sterility. The product contains B1, B2, B3, B6, Cyanocobalamin, Choline Chloride, Inositol, and Methionine. The recall involves 3,000 mL in vials.

The affected lots are 151220-5 with a best-use date of 05/26/16 and 160127-25 with a best-use date of 07/25/16. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

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

The recalled product

Product
M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML 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 (4)

  • Lot #: 151220-5
  • BUD: 05/26/16
  • Lot #: 160127-25
  • BUD: 07/25/16

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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