Drug product
fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05
D-1012-2017
Product summary
- Event
- Event 77770
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1012-2017
Official wording
Reason: Lack of Assurance of Sterility; product has the potential to leak.
Code information: Lot: 20170512@19 BUD: 8/10/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility