Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only,...

FDA Recall #D-0604-2016 — Class II — August 19, 2015

Recall #D-0604-2016 Date: August 19, 2015 Classification: Class II Status: Terminated

Product Description

Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, 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

400

Distribution

Nationwide

Code Information

All lots with expiration dates up to 11/17/2015

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated