D-1034-2017 Class II Terminated
FDA drug recall D-1034-2017 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 + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Distribution Pattern
Nationwide
Code Information
Lots: 20170509@17 BUD: 8/7/2017