FDA recall D-0878-2022

Monarch PCM, LLC · Class III · drug

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

Reason for recall

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

Distribution

TN only

Key facts

Status: Terminated
Initiation date: 2022-04-14
Report date: 2022-05-25
Termination date: 2023-06-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2022