D-0062-2018 Class II Terminated
FDA drug recall D-0062-2018 was initiated by SCA Pharmaceuticals, LLC on October 19, 2017 and is designated Class II. Reason for recall: Lack Of Assurance Of Sterility. The recall status is terminated (terminated May 1, 2019). Affected quantity: 116 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2017
- Initiation Date
- October 19, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116 bags
Product Description
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Reason for Recall
Lack Of Assurance Of Sterility.
Distribution Pattern
Nationwide in the United States
Code Information
Lot: 20170814@20 BUD: 11/12/2017