FDA Recall Hydromorphone Hydrochloride

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Hydromorphone Hydrochloride with NDC 0409-2552 was initiated on 08-22-2017 as a Class II recall due to lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. The latest recall number for this product is D-1167-2017 and the recall is currently terminated as of 02-19-2023 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1167-201708-22-201709-27-2017Class II115,370 vialsHYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)Terminated
D-020-201308-15-201210-31-2012Class I216,880 cartridge unitsHYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).Terminated
D-1444-201205-12-201208-15-2012Class I223,750 prefilled cartridge unitsHYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).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.