FDAClass IINovember 8, 2017

PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium recall: Sterility Concern

PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA…

Why was PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium 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: 20170920@53 BUD: 12/19/2017

Product
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
1221 syringes
Distribution
Nationwide in the United States
Recall date
November 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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