Home / Recalls / Vitae Enim Vitae Scientific, Inc. / D-0742-2022

D-0742-2022 Class II Terminated

Recalled by Vitae Enim Vitae Scientific, Inc. — San Diego, CA

Recall Details

Product Type
Drugs
Report Date
April 13, 2022
Initiation Date
March 14, 2022
Termination Date
August 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 2,098 boxes; b) 700 boxes

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the U.S.A

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

Other recalls by Vitae Enim Vitae Scientific, Inc.

  • D-0741-2022 Class II — TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single (March 14, 2022)
  • D-0744-2022 Class II — PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials p (March 14, 2022)
  • D-0743-2022 Class II — PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per (March 14, 2022)