FDAClass IIApril 3, 2024

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride recall: Sterility Concern

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals…

Why was PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride recalled?

Lack of Assurance of Sterility

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 #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24

Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
1,118 syringes in kits
Distribution
Nationwide in the USA
Recall date
April 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls