CLASS II Drug recall · Reported 8 Jan 2014 · FDA Enforcement Report
Daunorubicin Hydrochloride Injection, 20 mg recalled
Teva Pharmaceuticals USA is recalling Daunorubicin Hydrochloride Injection, 20 mg/ (5 mg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 11 Oct 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-392-2014
- FDA event ID
- 66594
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2013
- FDA classified
- 30 Dec 2013
- Reported
- 8 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Oct 2013 | Recall initiated by company | |
| 30 Dec 2013 | Classified by FDA | +80 days |
| 8 Jan 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Precipitate; precipitation of drug product
Product as listed by the FDA
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)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Precipitate; precipitation of drug product
Which lots are affected?
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 was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
All 281| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Daunorubicin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DAUNOrubicin Hydrochloride Injection 20 mg/ Single Dose vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |