Status
Terminated
Drug Enforcement D-392-2014
Presence of Precipitate; precipitation of drug product
Classification
Class II
Report Date
January 8, 2014
Termination Date
August 27, 2014
Product Information
- 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)
- Product quantity
- 13520 vials
- Reason for recall
- Presence of Precipitate; precipitation of drug product
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA
- Address
-
425 Privet Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-392-2014
- Event ID
- 66594
- Recall initiation date
- October 11, 2013
- Center classification date
- December 30, 2013
- 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
- More code info
- —