SCA Pharmaceuticals PHENYLephrine HCl Recall: FDA Class II

Why it was 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.

Product description

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1133-2015
Classification: Class II
Status: Terminated
Recall initiated: Apr 28, 2015
FDA report date: Jun 17, 2015
Quantity: 50 bags
Recall type: Voluntary: Firm initiated
Recalling firm: SCA Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-1133-2015, exactly as published.

Show all FDA fields

City: Little Rock
State: AR
Status: Terminated
Country: United States
Event ID: 71166
Address: 8821 Knoedl Ct
Code information: Lot: 20150423@47, Exp 07/22/15
Postal code: 72205-4600
Report date: Jun 17, 2015
Product type: Drugs
Recall number: D-1133-2015
Classification: Class II
Recalling firm: SCA Pharmaceuticals
Product quantity: 50 bags
Termination date: Dec 9, 2016
Reason for recall: 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.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: CA
Recall initiation date: Apr 28, 2015
Initial firm notification: Telephone
Center classification date: Jun 10, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1133-2015, published Jun 17, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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SCA Pharmaceuticals PHENYLephrine HCl 50 mg in 0 Recall

Summary