The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1228-2016·Announced 2016-07-20

Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/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 3/5 (High).

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 involves a risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Medaus, Inc. is recalling 157,500 mL of Sodium Ascorbate 500mg/mL (PF) in 10 mL, 50 mL, and 100 mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product.

The affected product was distributed nationwide in the United States, as well as in Japan and New Zealand. Specific lot numbers and expiration dates are listed in the recall documentation.

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

The recalled product

Product
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML 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 (14)

  • a) Lot #: 151217-47
  • BUD: 06/14/16
  • Lot #: 160112-51
  • BUD: 07/10/16
  • Lot #: 160127-43
  • BUD: 07/25/16
  • Lot #: 160218-8
  • BUD: 08/16/16
  • Lot #: 151211-26
  • BUD: 06/08/16. b) Lot #: 151211-26
  • BUD: 06/08/16
  • Lot #: 151217-47
  • BUD: 08/16/16. c) Lot #: 151211-26
  • 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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