D-0878-2022 Class III Terminated
FDA drug recall D-0878-2022 was initiated by Monarch PCM, LLC on Apr 14, 2022 and is designated Class III. Reason for recall: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content The recall status is terminated (terminated Jun 2, 2023). Affected quantity: 15,730 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 25, 2022
- Initiation Date
- Apr 14, 2022
- Termination Date
- Jun 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,730 bottles
Product Description
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 Pattern
TN only
Code Information
Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0878-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026