The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1214-2016·Announced 2016-07-20

Medaus Recalls Methyl B12 Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Methyl B12 1000mcg/mL 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Medaus, Inc. is recalling specific lots of Methyl B12 1000mcg/mL with preservative (benzalkonium 0.01% in NaCl 0.9%) in 2mL, 5mL, and 10mL vials. The recall is being conducted due to a lack of assurance of sterility. The affected product was distributed in the U.S. nationwide, Japan, and New Zealand.

The recall involves a total of 8,020 mL in vials. Specific lot numbers and best-use dates are listed in the structured product information. The source text does not report any illnesses or injuries associated with this recall.

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

The recalled product

Product
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and 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 (8)

  • a) Lot #: 151218-30
  • BUD: 06/15/16
  • Lot #: 151221-70
  • BUD: 06/18/16. b) Lot #: 151221-78
  • BUD: 06/18/16
  • Lot #: 160217-40
  • BUD: 08/15/16. c) Lot #: 151221-78
  • BUD: 08/15/16.

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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