FDAClass IIMay 31, 2023

HyperLyte CR Injection recall: Sterility Concern

HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code…

Why was HyperLyte CR Injection recalled?

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

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 # 37-874236, Exp 06/20/2023; 37-878694, Exp 07/10/2023

Product
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code…
Recalling firm
Central Admixture Pharmacy Services, Inc.
Quantity
554 bags
Distribution
Nationwide in the USA.
Recall date
May 31, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls