The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1193-2016·Announced 2016-07-20

Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific vials of Hydroxy 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for significant harm.

Plain-English summary

Medaus, Inc. is recalling 1 mL vials of Hydroxy B12 1000mcg/mL in NaCl 0.9% (PF). The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is identified by Lot # 160104-64 with a beyond-use date of 07/02/16.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved in the recall is 300 mL in vials.

Consumers and healthcare providers should discontinue use of the affected product and contact Medaus, Inc. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable
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 #: 160104-64
  • BUD: 07/02/16

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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