FDAClass IIJuly 25, 2018

ePHEDrine 50mg recall: Sterility Concern

ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of…

Why was ePHEDrine 50mg recalled?

Lack of Assurance of Sterility: Potential leakage of bags.

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 # 3/5/18 8055 80561S, 3/5/18 0514 80561S, 3/5/18 5259 80561S, 3/5/18 6131 80561S, 3/5/18 5641 80561S, BUD 7/3/2018; 5/10/18 1312 80561S, 5/10/18 1322 80561S, BUD 9/7/2018;

Product
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
5400 syringes
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls