Recalls / Class II

Class IID-1003-2016

Product

MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Affected lot / code info

Lot #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016: 85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016: 95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016: 01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016: 19@17 04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp. 05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016.

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-1003-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.