Recalls / Class II

Class IID-0994-2016

Product

M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Affected lot / code info

Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016: 87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp. 07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016 04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016.

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-0994-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.