FDAClass IIAugust 2, 2017

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride recall: Sterility Concern

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA…

Why was PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride recalled?

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

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: 20170710@3, BUD: 10/8/2017

Product
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA…
Recalling firm
SCA Pharmaceuticals
Quantity
2 bags
Distribution
Nationwide in the USA
Recall date
August 2, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls