Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #: B032223AA; Exp: July 2016
Why it was recalled
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 3,306 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-11-25
- FDA classified
- 2014-12-22
- Posted by FDA
- 2014-12-31
- Terminated
- 2016-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0313-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.