Recalls / Class II
Class IID-0959-2023
Product
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
- Affected lot / code info
- Lot: 36-240224, Exp. 7/16/2023; 36-242322, EXP. 7/24/2023; 36-242445, Exp. 7/25/2023; 36-243305, Exp. 7/27/2023; 36-243813, Exp. 7/31/2023; 36-246166, 36-246167, Exp. 8/3/2023; 36-247670, Exp. 8/9/2023; 36-248992, Exp.8/16/2023; 36-249468, Exp. 8/17/2023; 36-249590, Exp.8/18/2023; 36-251336, 36-251644, Exp. 8/27/2023; 36-251461, Exp. 8/28/2023; 36-255531, 36-255532, Exp. 9/7/2023.
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
- 4,570 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-0959-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.