FDAClass IIMay 8, 2019

Lipoplex recall: Sterility Concern

Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML)…

Why was Lipoplex recalled?

Lack of assurance of sterility for injectables and solutions intended to be sterile.

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 #: 02212019@13, Exp 5/22/19

Product
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML)…
Recalling firm
Customceutical Compounding
Quantity
16 vials
Distribution
U.S.A. Nationwide
Recall date
May 8, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls