The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1217-2016·Announced 2016-07-20

Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific vials of Methyl B12 injection due to a lack of assurance of sterility. The affected product was 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 source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product corresponds to a score of 4 (Severe), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Medaus, Inc. is recalling 2 mL vials of Methyl B12 1000mcg/mL in NaCl 0.9% (PF). The recall was initiated because of a lack of assurance of sterility in the product. The specific lot number is 151218-28, with a beyond-use date of 06/15/16.

The affected product was distributed nationwide in the United States, as well as in Japan and New Zealand. The source text does not specify the exact number of units recalled or the specific facilities where the product was distributed.

Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 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 (2)

  • Lot #: 151218-28
  • BUD: 06/15/16

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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