Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured ...

FDA Recall #D-0313-2015 — Class III — November 25, 2014

Recall #D-0313-2015 Date: November 25, 2014 Classification: Class III Status: Terminated

Product Description

Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.

Reason for Recall

Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,306 vials

Distribution

Nationwide

Code Information

Lot #: B032223AA; Exp: July 2016

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated