Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable p...
FDA Recall #D-0605-2016 — Class II — August 19, 2015
Product Description
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason for Recall
Stability data does not support expiry.
Recalling Firm
Pharmakon Pharmaceuticals — Noblesville, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
378
Distribution
Nationwide
Code Information
All lots with expiration dates up to 11/17/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated