PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2016 Initiated: May 17, 2016 #D-0979-2016

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.

Details

Units Affected
869 Units (Total All Products)
Distribution
NV
Location
Las Vegas, NV

Frequently Asked Questions

What product was recalled?
ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121. Recalled by Well Care Compounding Pharmacy. Units affected: 869 Units (Total All Products).
Why was this product recalled?
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2016. Severity: Moderate. Recall number: D-0979-2016.