The Recall Desk
HighFDA (Drugs)·D-1219-2016·Announced 2016-07-20

Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Methyl B12 10mg/mL vials because the company cannot guarantee the product is sterile.

What this means for you

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 failure) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Medaus, Inc. is recalling Methyl B12 10mg/mL with preservative (benzalkonium 0.01%) in NaCl 0.9%, available in 1mL, 5mL, and 10mL vials. The recall is being conducted because the company lacks assurance of the sterility of the affected products.

The affected products were distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 331 mL in vials. Specific lot numbers and expiration dates are listed in the recall documentation, with all affected lots having a best-use date of 07/11/16.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML 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 (13)

  • a) Lot #: 160201-11
  • BUD: 07/11/16
  • Lot #: 160215-13
  • Lot #: 160309-4
  • BUD: 07/11/16. b) Lot #: 160315-1
  • Lot #: 160201-11
  • Lot #: 160210-71
  • BUD: 07/11/16. c) Lot #: 160125-17
  • Lot #: 160210-35
  • Lot #: 160222-20
  • Lot #: 160204-46
  • Lot #: 160307-25
  • BUD: 07/11/16.

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 →

Related recalls

Same manufacturer · Medaus, Inc.

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Same hazard · sterility failure

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