FDAClass IIJuly 25, 2018

EPINEPHrine recall: Sterility Concern

EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced…

Why was EPINEPHrine 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 # 5/4/18 0300 58-85525P, BUD 6/18/2018; 5/10/18 1435 262-85525P, 5/10/18 1127 558-85525P, BUD 6/24/2018; 5/11/18 1327 457-85525P, BUD 6/25/2018; 5/14/18 0302 295-85525P, BUD 6/28/2018; 5/17/18 0500 558-85525P, BUD 7/1/2018; 5/24/18 1005 57-85525P, 5/24/18 1328 295-85525P, BUD 7/7/2018; 5/25/18 0302 295-85525P, BUD 7/9/2018; 5/30/18 0936 262-85525P, BUD 7/14/2018; 5/31/18 0805 558-85525P, BUD 7/17/2018.

Product
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
420 bags
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls