D-0872-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- May 18, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 bags
Product Description
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Distribution Pattern
Nationwide in the USA
Code Information
LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17