FDAClass IIAugust 15, 2018

5 mg/mL Ephedrine Sulfate recall: CGMP Deviations

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.

Why was 5 mg/mL Ephedrine Sulfate recalled?

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

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 181730039D, Exp 09/20/2018

Product
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
Recalling firm
PharMEDium Services, LLC
Quantity
450 Syringes
Distribution
Product was distributed throughout the United States
Recall date
August 15, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls