January 2019 FDA Recall Drug by Mcguff Compounding Pharmacy Services, Inc.
D-0802-2020 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Mcguff Compounding Pharmacy Services, Inc. on January 10, 2019 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0802-2020

Reason for Recall
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Initiated
01-10-2019
Reported
01-22-2020
Quantity
146 30 ml vials were dispensed

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84618
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
McGuff Compounding Pharmacy Services, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-20-2023
Product Description About Product Description
Full technical description of the 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 Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

Batch or Lot Expiration Information

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