Recalls / Class II

Class IID-0988-2016

Product

1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Affected lot / code info

Lot #: 01072016: 23@28, Exp. 04/06/2016; Lot #: 01082016: 27@1, Exp. 04/07/2016; Lot #:02012016:20@39, Exp. 05/01/2016; Lot #: 02022016:07@7, Exp.05/02/2016; Lot #: 02152016:29@50, Exp. 05/15/2016; Lot #: 02292016: 40@24, Exp.05/29/2016; Lot #: 02292016: 12@42 , Exp.05/29/2016; Lot #: 03042016:96@9, Exp.06/02/2016; Lot #: 03082016:59@34, Exp.06/08/2016 03142016:65@58, Exp.06/12/2016; Lot #: 03212016: 66@2, Exp.06/19/2016; Lot #: 03022016:50@38, Exp.06/23/2016; Lot #: 03302016: 93@11, Exp. 06/28/2016; Lot #: 04062016:79@22, Exp.07/07/2016; Lot #: 04122016 38@58, Exp.07/12/2016; Lot #: 04152016: 87@1, Exp. 07/14/2016; Lot #: 04152016:12@12, Exp. 07/14/2016; Lot #: 04222016: 55@27, Exp.07/21/2016

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-0988-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.