The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1187-2016·Announced 2016-07-20

Medaus Recalls Germanium Seso 100mg/mL Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Germanium Seso 100mg/mL vials because the FDA determined there is a lack of assurance of 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant health consequences (such as sterility issues in injectable products) are rated as Severe (4), as they are not explicitly Class I but involve significant risk.

Plain-English summary

Medaus, Inc. is voluntarily recalling specific lots of Germanium Seso 100mg/mL (PF), 10mL vials. The recall was initiated because the U.S. Food and Drug Administration determined there is a lack of assurance of sterility for the affected product.

The affected product includes 49 mL in vials from the following lots: 151229-21, 151229-25, 151229-31, and 160126-14. All affected lots have a best-use date of 06/26/16 or 07/24/16. 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 affected product and contact Medaus, Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
GERMANIUM SESO 100MG/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 #: 151229-21
  • BUD: 06/26/16
  • Lot #: 151229-25
  • Lot #: 151229-31
  • Lot #: 160126-14
  • BUD: 07/24/16

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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