FDA-Drug2023-08-09Class II

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

Hazard

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

Sold states
Nationwide in the USA
Affected count
3,699 bags
Manufactured in
2200 S 43rd Ave, N/A, Phoenix, AZ, United States
Products
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0953-2023

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