Recalls / Class II

Class IID-0986-2016

Product

GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

Affected lot / code info

Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016

Why it was recalled

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

Recalling firm

Firm

Well Care Compounding Pharmacy

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

3430 E Tropicana Ave Ste 9, N/A, Las Vegas, Nevada 89121-7345

Distribution

Quantity

869 Units (Total All Products)

Distribution pattern

NV

Timeline

Recall initiated

2016-05-17

FDA classified

2016-06-09

Posted by FDA

2016-06-15

Terminated

2017-01-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0986-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.