Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
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: While no illnesses or deaths are reported, this is a sterile IV drug product where lack of sterilization assurance presents a significant potential for serious harm if contamination occurred. The FDA Class II classification, combined with the theoretical but serious contamination risk inherent in compromised sterilization procedures, places this at the 'High' severity level.
Plain-English summary
Central Admixture Pharmacy Services, Inc. (Phoenix, Arizona) is recalling 235 bags of diltiazem 125 mg/125 mL intravenous solution (NDC 72196-6055-1, Lot #36-262537, expiration 9/19/2023) mixed with 0.9% sodium chloride for IV use.
The recall was initiated because the manufacturer could not provide adequate validation data for the sanitization cycles used in preparing these sterile IV bags. Without proper validation of sterilization procedures, the sterility of the product cannot be assured.
This product was distributed nationwide throughout the United States and may be in use at hospitals, healthcare facilities, pharmacies, and other healthcare settings that received these specific lot numbers.
Healthcare facilities should immediately discontinue use of this product and contact the manufacturer or their supplier for instructions regarding product returns or disposal. Questions may be directed to Central Admixture Pharmacy Services, Inc.
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 — Injectable / IV
- Affected units
- 235
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 (2)
- Lot# 36-262537
- Exp 9/19/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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