Drug product
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
D-0872-2017
Product summary
- Event
- Event 77314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 118 bags
- Official record key
drug-enforcement:D-0872-2017
Official wording
Reason: Lack of assurance of sterility: Product bags leaking at seam.
Code information: LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility