FDA recall D-1251-2019

Advanced Pharma Inc. · Class II · drug

Product

HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10

Reason for recall

Sub-potency

Distribution

Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2019-04-26
Report date: 2019-05-08
Termination date: 2019-10-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1251-2019