FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Lohxa Phenobarbital Oral Solution Recall

Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg

Lohxa LLC · Worcester, MA

Risk level
Class II
Reported by FDA
Apr 17, 2019
Recall ID
D-1131-2019
Check your lot numberHow we source this data

Summary

Lohxa recalled Phenobarbital Oral Solution starting Mar 25, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1131-2019 on Apr 17, 2019. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

MA, NY and WY

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1131-2019
Classification
Class II
Status
Terminated
Recall initiated
Mar 25, 2019
FDA report date
Apr 17, 2019
Quantity
46 boxes - 1380 unit dose cups
Recall type
Voluntary: Firm initiated
Recalling firm
Lohxa LLC

Original FDA data

Every field from FDA enforcement report D-1131-2019, exactly as published.

Show all FDA fields
City
Worcester
State
MA
Status
Terminated
Country
United States
Event ID
82538
Address
600 Main St Ste 110
Code information
Lot# M12031, Exp. 12/2019; T01241 Exp. 02/2020
Postal code
01608-2061
Report date
Apr 17, 2019
Product type
Drugs
Recall number
D-1131-2019
Classification
Class II
Recalling firm
Lohxa LLC
Product quantity
46 boxes - 1380 unit dose cups
Termination date
Jun 20, 2023
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
Distribution pattern
MA, NY and WY
Recall initiation date
Mar 25, 2019
Initial firm notification
Letter
Center classification date
Apr 15, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1131-2019, published Apr 17, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls