FDA Drug recall 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,…
- FDA Drug
- Class III
- terminated
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class III recall of Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624,… by Monarch Pcm, citing does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0878-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-04-14 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Monarch Pcm |
| Distribution | TN |
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
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Identifiers
| code_info | Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0878-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.