Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Ph...

FDA Recall #D-1261-2016 — Class II — April 20, 2016

Recall #D-1261-2016 Date: April 20, 2016 Classification: Class II Status: Terminated

Product Description

Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72

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

1575

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