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Class III: unlikely to cause harmTerminated

Monarch PCM Phenobarbital Elixir Recall

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured…

Monarch PCM, LLC · Fort Worth, TX

Risk level
Class III
Reported by FDA
May 25, 2022
Recall ID
D-0878-2022
Check your lot numberHow we source this data

Summary

Monarch PCM recalled Phenobarbital Elixir starting Apr 14, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0878-2022 on May 25, 2022. Reason: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content. Status: Terminated.

Why it was recalled

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

Product description

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

Lot numbers, UPCs & expiration codes

Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023

Where it was sold

TN only

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-0878-2022
Classification
Class III
Status
Terminated
Recall initiated
Apr 14, 2022
FDA report date
May 25, 2022
Quantity
15,730 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Monarch PCM, LLC

Original FDA data

Every field from FDA enforcement report D-0878-2022, exactly as published.

Show all FDA fields
City
Fort Worth
State
TX
Status
Terminated
Country
United States
Event ID
90062
Address
7333 Jack Newell Blvd N Ste 100
Code information
Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Postal code
76118-7151
Report date
May 25, 2022
Product type
Drugs
Recall number
D-0878-2022
Classification
Class III
Recalling firm
Monarch PCM, LLC
Product quantity
15,730 bottles
Termination date
Jun 2, 2023
Reason for recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
Distribution pattern
TN only
Recall initiation date
Apr 14, 2022
Initial firm notification
Letter
Center classification date
May 17, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0878-2022, published May 25, 2022. 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.

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