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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1

D-1013-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
2692 bags
Official record key
drug-enforcement:D-1013-2023

Official wording

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

Code information: Lot: 36-241803, 36-241804, Exp. 7/21/2023; 36-243836, Exp. 7/31/2023; 36-246645, Exp. 8/3/2023; 36-246729, Exp. 8/6/2023; 36-248976, Exp. 8/16/2023; 36-249502, Exp. 8/17/2023; 36-252215, 8/31/2023; 36-255872, 36-255875, Exp. 9/10/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility