The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1182-2016·Announced 2016-07-20

Medaus Recalls EDTA Disodium Vials Due to Sterility Concerns

Medaus, Inc. is recalling EDTA Disodium 15% vials because the company cannot ensure the product is sterile. The recall covers vials 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High (3) due to the agency's specific classification of the risk.

Plain-English summary

Medaus, Inc. is recalling EDTA Disodium 15% (150mg/mL) 20mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is identified by specific lot numbers and expiration dates, including Lot 151202-45, Lot 160105-38, Lot 160114-20, and Lot 160217-28.

The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The total quantity involved is 24,000 mL in vials. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a return. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable / Sterile Product
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 (8)

  • Lot #: 151202-45
  • BUD: 05/30/16
  • Lot #: 160105-38
  • BUD: 07/03/16
  • Lot #: 160114-20
  • BUD: 07/12/16
  • Lot #: 160217-28
  • BUD: 08/15/16

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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