FDAClass IIJanuary 22, 2020

Lipoic Acid Injection recall: Particulate Matter

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff…

Why was Lipoic Acid Injection recalled?

Presence of Particulate Matter: filmy/cloudy particulate observed in vial.

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 #: 18M0991, Preparation #: 390-2678, Beyond Usage Date: 06/15/2019

Product
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff…
Recalling firm
McGuff Compounding Pharmacy Services, Inc.
Quantity
146 30 ml vials were dispensed
Distribution
Distributed Nationwide in the US
Recall date
January 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls