Drug 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.
D-0313-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69900
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,306 vials
- Official record key
drug-enforcement:D-0313-2015
Official wording
Reason: Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Code information: Lot #: B032223AA; Exp: July 2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.