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Recall Observatory FDA recall evidence

Drug product

rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

D-1113-2023

August 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92898
Status
Terminated
Classification
Class II
Quantity
3519 Syringes
Official record key
drug-enforcement:D-1113-2023

Official wording

Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Code information: Lot# 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, 36-262730, Exp 10/11/2023 ;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility