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Recall Observatory FDA recall evidence

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

April 28, 2015

Class II

Product summary

Firm
SCA Pharmaceuticals
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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up