PlainRecalls
FDA Drug Moderate Class II Terminated

HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.

Reported: May 31, 2023 Initiated: April 28, 2023 #D-0754-2023

Product Description

HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.

Reason for Recall

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

Details

Units Affected
554 bags
Distribution
Nationwide in the USA.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 554 bags.
Why was this product recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 31, 2023. Severity: Moderate. Recall number: D-0754-2023.