Recalls / Class II
Class IID-0953-2023
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
- Affected lot / code info
- 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, Exp. 8/21/2023; 36-256890, Exp. 8/25/2023.
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 3,699 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-14
- FDA classified
- 2023-08-01
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0953-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.