FDA Recall Hydromorphone Hydrochloride

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Hydromorphone Hydrochloride with NDC 0703-0110 was initiated on 02-07-2018 as a Class I recall due to non-sterility: confirmed customer complaints of glass product container vials that may be empty or cracked. The latest recall number for this product is D-0596-2018 and the recall is currently terminated as of 08-07-2019 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0596-201802-07-201803-21-2018Class I53600 vialsHydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01Terminated
D-1080-201707-26-201708-16-2017Class II14,300 vialsHydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01Terminated
D-1082-201707-26-201708-16-2017Class II56,340 vialsHydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.Terminated
D-0044-201510-01-201410-29-2014Class II145,600 vialsHydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.