Drug product
PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40
D-1028-2017
Product summary
- Event
- Event 77770
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1028-2017
Official wording
Reason: Lack of Assurance of Sterility; product has the potential to leak.
Code information: Lot: 20170503@16 BUD: 8/1/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility