FDA recall D-0875-2017

Product

HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55

Reason for recall

Lack of assurance of sterility: Product bags leaking at seam.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-05-18

Report date

2017-06-07

Termination date

2018-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0875-2017