Teva Recalls Daunorubicin Hydrochloride Injection Due to Precipitate Presence
Teva Pharmaceuticals USA is recalling specific lots of Daunorubicin Hydrochloride Injection because the drug product contains precipitate.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant product defects like precipitate in injectable drugs are categorized as Severe.
Plain-English summary
Teva Pharmaceuticals USA is recalling 13,520 vials of Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial. The product is manufactured by Teva Parenteral Medicines, Inc., in Irvine, California, and is labeled with NOVAPlus labels. The recall covers specific lot numbers with expiration dates ranging from February 2014 to December 2014.
The recall was initiated due to the presence of precipitate, which is the precipitation of the drug product. This condition affects the physical integrity of the medication.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- 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-
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Medication
- Affected units
- 13,520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Lot number EXP 31314801B
- 2/2014
- 31314990B
- 31314991B
- 31315014B
- 31315155B
- 6/2014
- 31315279B
- 31315837B
- 10/2014
- 31315921B
- 31316029D
- 12/2014
- and 31316029C
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · precipitate
See all →- HighMycophenolate Mofetil Injection Recalled Due to Precipitate in Vials
FDA (Drugs) · 2026-08-05
- ModerateCyproheptadine Hydrochloride Syrup Recall Due to Precipitate
FDA (Drugs) · 2026-07-29
- ModerateUS Worldmeds Recalls Revonto Dantrolene Sodium Injection Due to Precipitate
FDA (Drugs) · 2019-05-08
- LowPromise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate
FDA (Drugs) · 2018-10-31
- SevereSCA Pharmaceuticals Recalls Furosemide Injection Bags Due to Precipitate
FDA (Drugs) · 2018-09-19