Recalls / Class II
Class IID-392-2014
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)
- Affected 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
Why it was recalled
Presence of Precipitate; precipitation of drug product
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 13520 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-11
- FDA classified
- 2013-12-30
- Posted by FDA
- 2014-01-08
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-392-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.