FDAClass IIApril 17, 2019

Phenobarbital Oral Solution recall: Labeling Error

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

Why was Phenobarbital Oral Solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# M12031, Exp. 12/2019; T01241 Exp. 02/2020

Product
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
Recalling firm
Lohxa LLC
Quantity
46 boxes - 1380 unit dose cups
Distribution
MA, NY and WY
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls