Recalls / Class II
Class IID-0958-2023
Product
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
- Affected lot / code info
- Lot: 36-239245, Exp. 7/10/2023; 36-241047, Exp. 7/18/2023; 36-241440, 36-241441, 36-241442, Exp. 7/20/2023; 36-242432, Exp. 7/25/2023; 36-243662, Exp. 7/30/2023; 36-246152, 36-246153, 36-246158, Exp. 8/3/2023; 36-246730, 36-246731, 36-246732, Exp. 8/6/2023; 36-247332, 36-247334, 36-247337, Exp. 8/8/2023; 36-249469, Exp. 8/17/2023; 36-249589, Exp. 8/18/2023; 36-250300, Exp. 8/23/2023; 36-251335, Exp. 8/27/2023; 36-254370, Exp. 9/4/2023.
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
- 6,784 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-0958-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.