The Recall Desk
SevereFDA (Drugs)·D-1192-2016·Announced 2016-07-20

Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Hydroxy B12 1000mcg/mL vials because the company cannot ensure the product is sterile.

What this means for you

Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable product) without reported fatalities or hospitalizations is categorized as Severe (Score 4).

Plain-English summary

Medaus, Inc. is recalling 7,000 mL of Hydroxy B12 1000mcg/mL vials (with Benzalkonium 0.01% preservative) in 10 mL vials. The recall is being conducted because the company lacks assurance of the product's sterility.

The affected product was distributed nationwide in the United States, as well as in Japan and New Zealand. The specific lots subject to the recall are 151221-56 (Best Use Date: 06/18/16), 160203-23 (Best Use Date: 08/01/16), and 160218-45 (Best Use Date: 08/16/16).

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The FDA classifies this as a Class II recall, 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 W/PRES (BENZALKONIUM 0.01%), 10ML 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 (6)

  • Lot #: 151221-56
  • BUD: 06/18/16
  • Lot #: 160203-23
  • BUD: 08/01/16
  • Lot #: 160218-45
  • BUD: 08/16/16

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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