The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1176-2016·Announced 2016-07-20

Medaus Recalls Calcium Sodium EDTA Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Calcium Sodium EDTA 300mg/mL vials because the agency cannot assure the product's sterility.

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 this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility assurance issues for injectable pharmaceuticals.

Plain-English summary

Medaus, Inc. is recalling 8,500 mL of Calcium Sodium EDTA 300mg/mL (PF) 10mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product.

The affected product includes vials from Lot # 151123-11 (Best Use Date: 05/21/16), Lot # 160105-24 (Best Use Date: 07/03/16), and Lot # 160118-7 (Best Use Date: 07/16/16). The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CALCIUM SODIUM EDTA 300MG/ML (PF), 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 # : 151123-11
  • BUD: 05/21/16
  • Lot #: 160105-24
  • BUD: 07/03/16
  • Lot #: 160118-7
  • BUD: 07/16/16

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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