FDA-Drug2022-05-25Class III
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
Monarch PCM, LLC
Hazard
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Sold states
TN only
Affected count
15,730 bottles
Manufactured in
7333 Jack Newell Blvd N Ste 100, N/A, Fort Worth, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2022Don't want to check this manually?
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