Drug product
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
D-1004-2017
Product summary
- Event
- Event 77777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bags
- Official record key
drug-enforcement:D-1004-2017
Official wording
Reason: Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Code information: Lot: 20170710@3, BUD: 10/8/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility