D-1022-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- January 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 869 Units (Total All Products)
Product Description
VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Distribution Pattern
NV
Code Information
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.