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

Recall Number: D-0878-2022

Firm: Monarch PCM, LLC

Classification: Class III

Status: Terminated

Report Date: 20220525

Initiation Date: 20220414

Termination Date: 20230602

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

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