FDA recall D-0313-2015

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-11-25

Report date

2014-12-31

Termination date

2016-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0313-2015