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Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable pa...

FDA Recall #D-0607-2016 — Class II — August 19, 2015

Recall #D-0607-2016 Date: August 19, 2015 Classification: Class II Status: Terminated

Product Description

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 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

N/A

Distribution

Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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