IV Medication Recall: dilTIAZem Bags Lack Sterility Assurance
Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.
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 is an FDA Class II recall of IV medication with sterility assurance failures. Although no hospitalizations or illnesses are reported in the source, the product poses significant risk of harm if contaminated IV medication is administered. This fits the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 3,699 bags of dilTIAZem 125mg/125mL (1 mg/mL) prepared in 0.9% sodium chloride for intravenous use. The medication was distributed nationwide.
The recall is due to lack of assurance of sterility and lacking validation data for decontamination cycles used in the manufacture of these products. This means the company cannot confirm that these IV bags are sterile.
The recalled lots are: 36-244893, 36-244894, 36-244895 (expiring 7/12/2023); 36-246428, 36-246429, 36-246647, 36-246648 (expiring 7/14/2023); 36-254364, 36-254365, 36-254366, 36-254367, 36-254368 (expiring 8/15/2023); 36-246824, 36-246825, 36-246828 (expiring 7/18/2023); 36-256157 (expiring 8/21/2023); and 36-256890 (expiring 8/25/2023). Healthcare providers and patients should not use this product.
The recalled product
- Product
- 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
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Medication
- Affected units
- 3,699
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 (20)
- Lot: 36-244893
- 36-244894
- 36-244895
- Exp. 7/12/2023
- 36-246428
- 36-246429
- 36-246647
- 36-246648
- Exp. 7/14/2023
- 36-254364
- 36-254365
- 36-254366
- 36-254367
- 36-254368
- Exp. 8/15/2023
- 36-246824
- 36-246825
- 36-246828
- Exp. 7/18/2023
- 36-256157
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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