HYDROMORPHONE HYDROCHLORIDE

Generic: HYDROMORPHONE HYDROCHLORIDE

Fresenius Kabi USAManufacturer

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRoute

HYDROMORPHONE HYDROCHLORIDEActive Substance

1984-01-11Original Approval

HYDROMORPHONE HYDROCHLORIDE is FDA application NDA019034, sponsored by FRESENIUS KABI USA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2014-10-01

Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01),

Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that

Class II2017-07-26

Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral M

Presence of Particulate Matter: Silicone oil

Class I2012-05-12

HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-coun

Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be ov

Class I2018-02-07

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. H

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or c

Class II2017-07-26

Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per ca

Presence of Particulate Matter: Silicone oil

Class II2017-08-22

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc.,

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in

Class I2012-08-15

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-coun

Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled a

Class I2018-02-07

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mf

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or c

Class II2017-07-26

Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0

HYDROMORPHONE HYDROCHLORIDE

Recalls

Top Reported Reactions