Recalls / Class II

Class IID-1022-2016

Product

VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Affected lot / code info

Lot #: 01182016:09@28, Exp. 02/01/2016; Lot #: 03072016:50@49, Exp. 03/21/2016; Lot #: 03232016: 79@7, Exp. 04/06/2016; Lot #:03282016:15@10, Exp. 04/11/2016; Lot #: 04192016:35@14, Exp.07/19/2016.

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-1022-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.