The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1191-2016·Announced 2016-07-20

Medaus Recalls Hydroxy B12 Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.

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 and involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Medaus, Inc. is recalling Hydroxy B12 5mg/mL in NaCl 0.9% (PF) in 1 mL and 2 mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product.

The affected lots are 160119-8 (Best Use Date: 07/17/16) and 160204-30 (Best Use Date: 08/02/16). The total quantity involved is 800 mL in vials. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

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

The recalled product

Product
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML 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 (5)

  • a) Lot #: 160119-8
  • BUD: 07/17/16
  • Lot #: 160204-30
  • BUD: 08/02/16. b) Lot #: 160119-8
  • BUD: 08/02/16.

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 →

Related recalls

Same manufacturer · Medaus, Inc.

See all →

Same hazard · lack of sterility

See all →

Similar recalls