FDA recall D-0080-2018

Product

Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40

Reason for recall

Superpotent drug: out of specification result for potency

Distribution

CA, IL

Key facts

Status

Terminated

Initiation date

2017-10-13

Report date

2017-11-22

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2018