FDA recall D-1488-2019

Product

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

Reason for recall

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-06-07

Report date

2019-07-10

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1488-2019