D-0313-2015 Class III Terminated
FDA drug recall D-0313-2015 was initiated by Hospira Inc. on Nov 25, 2014 and is designated Class III. Reason for recall: Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions. The recall status is terminated (terminated Dec 15, 2016). Affected quantity: 3,306 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 31, 2014
- Initiation Date
- Nov 25, 2014
- Termination Date
- Dec 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,306 vials
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.
Distribution Pattern
Nationwide
Code Information
Lot #: B032223AA; Exp: July 2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0313-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026