FDAClass IIJune 17, 2015

PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride recall: Labeling Error

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…

Why was PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 20150423@47, Exp 07/22/15

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…
Recalling firm
SCA Pharmaceuticals
Quantity
50 bags
Distribution
CA
Recall date
June 17, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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