FDA recalls dilTIAZem IV bags due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a high-risk product—an intravenous medication intended for direct bloodstream administration. Although no illnesses or hospitalizations have been reported, the lack of validation data for decontamination cycles constitutes a sterility assurance issue for a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 2,260 bags of dilTIAZem 125mg/125mL (1 mg/mL) formulated in dextrose 5% solution for intravenous administration. The product is manufactured by Central Admixture Pharmacy Services, Inc., located in Phoenix, Arizona, and was distributed nationwide.
The FDA identified that validation data for decontamination cycles is lacking. This creates uncertainty about whether the product meets sterility assurance requirements necessary for safe intravenous administration.
Healthcare facilities and hospitals that have received the affected lots should immediately stop using the product and contact Central Admixture Pharmacy Services for instructions on return or disposal. Affected lot numbers are: 36-243946, 36-243947, 36-243948, 36-243949 (expires 7/11/2023); 36-255120 (expires 8/17/2023); 36-246829, 36-246831, 36-246832 (expire 7/18/2023); 36-255961 (expires 8/21/2023); and 36-256896 (expires 8/25/2023).
The recalled product
- Product
- dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous
- Hazard
- Affected units
- 2,260
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot: 36-243946
- 36-243947
- 36-243948
- 36-243949
- Exp. 7/11/2023
- 36-255120
- Exp. 8/17/2023
- 36-246829
- 36-246831
- 36-246832
- Exp. 7/18/2023
- 36-255961
- Exp. 8/21/2023
- 36-256896
- Exp. 8/25/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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