Recalls / Class II
Class IID-0977-2023
Product
heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
- Affected lot / code info
- Lot: 36-243815, 36-243816, Exp. 7/11/2023; 36-247675, 36-247676, Exp. 7/20/2023; 36-247837, Exp. 7/21/2023; 36-248988, 36-248989, Exp. 7/27/2023; 36-249594, 36-249595, Exp. 7/29/2023; 36-249833, Exp. 8/1/2023; 36-251054, 36-251055, 36-251056, Exp. 8/4/2023; 36-251943, 36-251951, 36-251961, Exp. 8/10/2023; 36-254376, 36-254377, 36-254378, Exp. 8/15/2023; 36-254689, 36-254691, 36-254692, Exp. 8/16/2023; 36-255493, Exp. 8/18/2023; 36-255945, 36-255946, 36-255957, Exp. 8/21/2023.
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
- 7,509 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-0977-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.