April 2022 FDA Recall Drug by Monarch Pcm, Llc
D-0878-2022 - Does Not Meet USP or OTC Monograph

This Class III drug recall was voluntarily initiated by Monarch Pcm, Llc on April 14, 2022 for the product Drug. The FDA reported the reason for recall as does not meet usp or otc monograph. The product was distributed in TN only and the recall is currently terminated.

Recall Number: D-0878-2022

Reason for Recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Initiated
04-14-2022
Reported
05-25-2022
Quantity
15,730 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90062
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Monarch PCM, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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