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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1

D-0973-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
3821 bags
Official record key
drug-enforcement:D-0973-2023

Official wording

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

Code information: Lot: 36-241662, Exp. 7/20/2023; 36-242725, Exp. 7/26/2023; 36-243607, Exp. 7/30/2023; 36-243837, 36-243838, Exp. 7/31/2023; 36-245517, 36-245523, 36-245525, 36-245662, Exp. 8/2/2023; 36-247254, 36-247255, Exp. 8/8/2023; 36-247983, Exp. 8/10/2023; 36-254917, Exp. 9/5/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility