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 31314801B2/201431314990B2/201431314991B2/201431315014B2/201431315155B6/201431315279B6/201431315837B10/201431315921B10/201431316029D12/2014and 31316029C12/2014
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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