FDA recall D-1131-2019

Lohxa LLC · Class II · drug

Product

Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.

Distribution

MA, NY and WY

Key facts

Status: Terminated
Initiation date: 2019-03-25
Report date: 2019-04-17
Termination date: 2023-06-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Worcester, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1131-2019