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Recall Observatory FDA recall evidence

Drug product

phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.

D-0962-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
1,853 bags.
Official record key
drug-enforcement:D-0962-2023

Official wording

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

Code information: Lot: 36-249691, 36-249692, Exp. 8/20/2023; 36-250052, 36-250053, Exp. 8/22/2023; 36-251062, Exp. 8/24/2023; 36-251992, Exp. 8/30/2023; 36-252467, Exp. 9/3/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility