The Recall Desk
HighFDA (Drugs)·D-1138-2023·Announced 2023-09-06

dilTIAZem IV Bags Recalled Due to Lack of Sterilization Validation

Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.

What this means for you

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: FDA classified this as a Class II drug recall. Although no illnesses or hospitalizations have been reported, the lack of validated sterilization for an intravenous medication represents a significant risk of harm to patients. This meets 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 703 bags of dilTIAZem 125mg/125mL IV solution added to dextrose 5% due to lack of assurance of sterility. The company failed to adequately validate the sanitization cycles used in manufacturing, raising concerns about whether the sterilization process effectively prevents microbial contamination.

The affected medication was distributed nationwide. Three lot numbers are involved: Lot 36-260048 (expiration 9/13/2023), Lot 36-262174 (expiration 9/15/2023), and Lot 36-262523 (expiration 9/19/2023). The product's NDC number is 72196-6054-1.

Healthcare providers should immediately check inventory to identify patients who may have received this medication from the affected lots. Patients and providers should consult with each other about whether additional monitoring is warranted. The FDA has classified this as a Class II recall, indicating the defect could potentially cause adverse health effects.

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 Medication
Hazard
  • sterility-assurance-failure
  • contamination

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 (6)

  • Lot# 36-260048
  • Exp 9/13/2023
  • 36-262174
  • Exp 9/15/2023
  • 36-262523
  • Exp 9/19/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category