RecallDepth
Class II Terminated

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)

Company
Teva Pharmaceuticals Usa
Recall Initiated
October 11, 2013
Posted
January 8, 2014
Recall Number
D-392-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
13520 vials
Firm Location
Horsham, PA, United States

Reason for Recall

Presence of Precipitate; precipitation of drug product

Distribution

Nationwide

Lot / Code Info

Lot number EXP 31314801B, 2/2014; 31314990B, 2/2014; 31314991B, 2/2014; 31315014B, 2/2014; 31315155B, 6/2014; 31315279B, 6/2014; 31315837B, 10/2014; 31315921B, 10/2014; 31316029D, 12/2014; and 31316029C, 12/2014

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