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Recall Observatory FDA recall evidence

Drug product

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)

D-392-2014

October 11, 2013

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 66594
Status
Terminated
Classification
Class II
Quantity
13520 vials
Official record key
drug-enforcement:D-392-2014

Official wording

Reason: Presence of Precipitate; precipitation of drug product

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Presence of Precipitate; precipitation of drug product