Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,...

FDA Recall #D-1262-2016 — Class II — April 20, 2016

Recall #D-1262-2016 Date: April 20, 2016 Classification: Class II Status: Terminated

Product Description

Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Pharmakon Pharmaceuticals, Inc. — Noblesville, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

12

Distribution

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Code Information

All Sterile Compounded Products within Expiry

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated