FDAClass IIAugust 9, 2023

heparin 2500 units added to 0.9% sodium chloride recall: Sterility Concern

heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200…

Why was heparin 2500 units added to 0.9% sodium chloride recalled?

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

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: 36-249694, 36-249695, Exp. 7/31/2023.

Product
heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200…
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
358 bags
Distribution
Nationwide in the USA
Recall date
August 9, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls