Drug product
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
D-0879-2017
Product summary
- Event
- Event 77314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 bags
- Official record key
drug-enforcement:D-0879-2017
Official wording
Reason: Lack of assurance of sterility: Product bags leaking at seam.
Code information: LOT # 20170511@17, Use By: 08/09/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility