The Recall Desk
HighFDA (Drugs)·D-0951-2023·Announced 2023-08-09

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.

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: 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
  • contamination-risk

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.

Related recalls

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