Recalls / Class II
Class IID-0979-2023
Product
heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
- Affected lot / code info
- Lot: 36-246161, Exp. 7/14/2023; 36-247002, 36-247006, 36-247007, Exp. 7/18/2023; 36-247673, 36-247674, Exp. 7/20/2023; 36-247832, 36-247833, 36-247835, 36-247836, Exp. 7/21/2023; 36-248991, Exp. 7/27/2023; 36-249593, Exp. 7/29/2023; 36-250046, Exp. 8/2/2023; 36-251444, 36-251445, 36-251446, 36-251447, Exp. 8/8/2023; 36-251968, Exp. 8/10/2023; 36-254379, 36-254380, Exp. 8/15/2023; 36-254684, Exp. 8/16/2023.
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
- 5,834 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-0979-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.