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FDARecalled May 31, 2023 · #D-0712-2023

dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6054-1.

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
dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6054-1.
Type
Drugs
Manufacturer
Central Admixture Pharmacy Services, Inc.
Model numbers
37-896365
UPCs