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Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westm...

FDA Recall #D-0878-2022 — Class III — April 14, 2022

Recall #D-0878-2022 Date: April 14, 2022 Classification: Class III Status: Terminated

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

Reason for Recall

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

Recalling Firm

Monarch PCM, LLC — Fort Worth, TX

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

15,730 bottles

Distribution

TN only

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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