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Recall Observatory FDA recall evidence

Drug 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

D-0977-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
7,509 bags
Official record key
drug-enforcement:D-0977-2023

Official wording

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Code information: 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.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility