D-1014-2017 Class II Terminated
FDA drug recall D-1014-2017 was initiated by SCA Pharmaceuticals on July 14, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; product has the potential to leak. The recall status is terminated (terminated May 1, 2019). Affected quantity: N/A.
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
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Distribution Pattern
Nationwide
Code Information
Lots: 20170502@47 BUD: 7/31/2017; 20170502@56 BUD: 7/31/2017; 20170505@26 BUD: 8/3/2017; 20170506@25 BUD: 8/4/2017