FDAClass IIJuly 20, 2016

Thiamine 100 Mg/ml W/pres recall: Sterility Concern

THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

Why was Thiamine 100 Mg/ml W/pres 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?

Lot #: 160129-2, BUD: 06/07/16; Lot #: 160201-10, BUD: 06/07/16; Lot #: 160222-19, BUD: 06/07/16; Lot #: 160215-12, BUD: 06/07/16; Lot #: 160315-2, BUD: 06/07/16

Product
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
Recalling firm
Medaus, Inc.
Quantity
213 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