D-1005-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2017
- Initiation Date
- July 14, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Distribution Pattern
Nationwide
Code Information
Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017