Daunorubicin Hydrochloride Injection (Teva) – drug precipitation (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
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
Products Sold
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
Teva Pharmaceuticals USA is recalling Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV U due to Presence of Precipitate; precipitation of drug product. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Precipitate; precipitation of drug product
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026