The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1237-2016·Announced 2016-07-20

Medaus Recalls Riboflamin Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling specific lots of Riboflavin 10mg/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 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class I or USDA Class I recalls must be scored at least 4, and Class II recalls involving significant risks like sterility issues are categorized as Severe.

Plain-English summary

Medaus, Inc. is recalling specific lots of Riboflavin 10mg/mL (PF) vials, available in 1 mL and 2 mL sizes, due to a lack of assurance of sterility. The affected products are distributed in 35 mL vials.

The recall includes the following lots: 151123-74 (Best Use Date 05/21/16), 160315-10 (Best Use Date 09/11/16), and 160204-21 (Best Use Date 08/02/16). These products were 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 stop using the affected products. 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
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Medication
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 (5)

  • a) Lot #: 151123-74
  • BUD: 05/21/16
  • Lot #: 160315-10
  • BUD: 09/11/16. b) Lot #: 160204-21
  • BUD: 08/02/16.

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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