PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 17, 2019 Initiated: March 25, 2019 #D-1131-2019

Product Description

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.

Details

Recalling Firm
Lohxa LLC
Units Affected
46 boxes - 1380 unit dose cups
Distribution
MA, NY and WY
Location
Worcester, MA

Frequently Asked Questions

What product was recalled?
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02. Recalled by Lohxa LLC. Units affected: 46 boxes - 1380 unit dose cups.
Why was this product recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1131-2019.