Drug product
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
D-0066-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1221 syringes
- Official record key
drug-enforcement:D-0066-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lot: 20170920@53 BUD: 12/19/2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility