FDAClass ISeptember 30, 2015

PHENYLephrine HCl recall: Particulate Matter

PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50

Why was PHENYLephrine HCl recalled?

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

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 #: 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15

Product
PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50
Recalling firm
Pharmedium Services, LLC
Quantity
24 bags
Distribution
Nationwide
Recall date
September 30, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls