FDAClass IIJuly 20, 2016

Riboflavin 10mg/ml recall: Sterility Concern

RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY

Why was Riboflavin 10mg/ml recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Recalling firm
Medaus, Inc.
Quantity
35 mL in Vials
Distribution
U.S. Nationwide, Japan, and New Zealand.
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls