D-0979-2016 Class II Terminated

Recalled by Well Care Compounding Pharmacy — Las Vegas, NV

Recall Details

Product Type
Drugs
Report Date
June 15, 2016
Initiation Date
May 17, 2016
Termination Date
January 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
869 Units (Total All Products)

Product Description

ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for Recall

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Distribution Pattern

NV

Code Information

Lot #: 01252016:40@31, Exp. 04/27/2016; Lot #: 03072016:78@19, Exp. 06/6/2016; Lot #: 02222016:71@35, Exp. 05/27/2016