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)
Reported: January 8, 2014 Initiated: October 11, 2013 #D-392-2014
Product Description
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)
Reason for Recall
Presence of Precipitate; precipitation of drug product
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 13520 vials
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Teva Pharmaceuticals USA. Units affected: 13520 vials.
Why was this product recalled? ▼
Presence of Precipitate; precipitation of drug product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2014. Severity: Moderate. Recall number: D-392-2014.
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