Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,
Summary
The FDA issued a Class III for Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufa by Monarch PCM, LLC. Reason: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content.
Details
Source
Drug Recall
External ID
D-0878-2022
Action Date
2022-05-25
Status
Terminated
Category
drug
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/Code Info: Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Quantity Affected: 15,730 bottles
Reason for Recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Distribution
TN only
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-14
Company
Fort Worth, TX
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Monarch PCM, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Monarch PCM, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Monarch PCM, LLC have FDA actions?
Monarch PCM, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0878-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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