The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1188-2016·Announced 2016-07-20

Medaus Recalls Hyaluronidase Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Hyaluronidase 500U/ML vials because the company cannot assure the sterility of the product. The recall affects lots 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are provided to elevate it to Critical, but the risk is significant enough to warrant a high severity rating.

Plain-English summary

Medaus, Inc. is recalling Hyaluronidase 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY. The recall was initiated because the company lacks assurance of the sterility of the affected product. The specific lot number is 151230-23, with a beyond-use date of 06/27/16.

The affected product was distributed to Medaus Pharmacy and was available in the United States, Japan, and New Zealand. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of this product.

Consumers and healthcare providers should stop using the affected lot and contact Medaus, Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
HYALURONIDASE 500U/ML(PF), 3ML 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 (2)

  • Lot #: 151230-23
  • BUD: 06/27/16

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 · sterility failure

See all →

Similar recalls