Why it was recalled
Presence of Precipitate; precipitation of drug product
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)
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-392-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 11, 2013
- FDA report date
- Jan 8, 2014
- Quantity
- 13520 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-392-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66594
- Address
- 425 Privet Rd
- Code information
- 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
- Postal code
- 19044-1220
- Report date
- Jan 8, 2014
- Product type
- Drugs
- Recall number
- D-392-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 13520 vials
- Termination date
- Aug 27, 2014
- Reason for recall
- Presence of Precipitate; precipitation of drug product
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 30, 2013