FDAClass IIJuly 20, 2016

Niacinamide 100 Mg/ml recall: Sterility Concern

NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Why was Niacinamide 100 Mg/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 #: 160204-29, BUD: 08/02/16. b) Lot #: 151123-73, BUD: 05/21/16; Lot #: 151124-42, BUD: 05/22/16; Lot #: 151201-20, BUD: 05/29/16; Lot #: 151215-10, BUD: 06/12/16; Lot #: 160229-46, BUD: 07/17/16; Lot #: 160202-33, BUD: 07/31/16. c) Lot #: 160315-9, BUD: 09/11/16.

Product
NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Recalling firm
Medaus, Inc.
Quantity
104 mL in Vials
Distribution
U.S. Nationwide, Japan, and New Zealand.
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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