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Recall Observatory FDA recall evidence

Drug product

vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.

D-0747-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
1858 bags
Official record key
drug-enforcement:D-0747-2023

Official wording

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: Lot # 37-886252, 37-886254, Exp 05/11/2023; 37-889741, 37-889746, Exp 05/25/2023; 37-891444, Exp 06/01/2023; 37-893155, 37-893156, Exp 06/08/2023; 37-896812, Exp 06/22/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility