Reported Jan 8, 2014 · Terminated

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only,…

Teva Pharmaceuticals USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 425 Privet Rd · Horsham, PA · 19044-1220

Is this the product you have?

  • Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only
  • Manufactured ByTeva 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)
Lot codes and dates
    • 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
Amount recalled
13520 vials

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Presence of Precipitate; precipitation of drug product

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 27, 2014 · Data as of Sep 19, 5:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.