FDAFDA · Food and drugs·Recall number D-0878-2022
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
Published May 25, 2022 · Recall initiated: April 14, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Monarch PCM, LLC
- Distributor
- TN only
- Lot
- Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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