Monarch PCM, LLC recalls Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,
Recalled May 25, 2022 · FDA recall D-0878-2022 · Monarch PCM
Hazard
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content · FDA Class III
Units
15,730 bottles
Sold at
TN only
Description
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
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
Manufacturer(s)
Monarch PCM, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →