Phenobarbital Elixir — Class III drug recall D-0878-2022
Terminated recall by Monarch PCM, LLC, reported 2022-05-25, distributed in TN. Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
| Recall number | D-0878-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monarch PCM, LLC, Fort Worth, TX, United States |
| Recall initiated | 2022-04-14 |
| Classified | 2022-05-17 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-06-02 |
| Distributed | TN |
| Quantity | 15,730 bottles |
| NDC | 69367-0172-16 |
| Lot numbers | 20FP1569, 21FP1674, 21FP1831 |
| Expiration dates | 2022-08, 2023-02, 2023-08 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0878-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.