FDAClass IIJuly 20, 2016

Lipo-injection W/lidocaine W/pres recall: Sterility Concern

LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE…

Why was Lipo-injection W/lidocaine 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?

a) Lot #: 160104-40, BUD: 05/26/16; Lot #: 160209-28, BUD: 07/31/16. b) Lot #: 160104-40, BUD: 05/26/16; Lot #: 160209-28, BUD: 07/31/16.

Product
LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE…
Recalling firm
Medaus, Inc.
Quantity
14000 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