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Recall Observatory FDA recall evidence

Drug product

PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.

D-0742-2022

March 14, 2022

Class II

Product summary

Firm
Vitae Enim Vitae Scientific, Inc.
Event
Event 89803
Status
Terminated
Classification
Class II
Quantity
a) 2,098 boxes; b) 700 boxes
Official record key
drug-enforcement:D-0742-2022

Official wording

Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information: Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023

Distribution pattern: Nationwide in the U.S.A

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    deviations from Current Good Manufacturing Practices
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility