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FDARecalled May 31, 2023 · #D-0754-2023

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

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Classification: Class II Distribution: Nationwide in the USA.

Product details

Product
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
Type
Drugs
Manufacturer
Central Admixture Pharmacy Services, Inc.
Model numbers
37-874236
UPCs