Drug product
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.
D-1133-2015
Product summary
- Event
- Event 71166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 bags
- Official record key
drug-enforcement:D-1133-2015
Official wording
Reason: Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Code information: Lot: 20150423@47, Exp 07/22/15
Distribution pattern: CA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up