Food, drugs, devices › Monarch PCM, LLC
Drug recall: Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, L
Monarch PCM, LLC (Fort Worth, TX) initiated this drug recall on 14 Apr 2022; FDA lists 1 product record under event 90062, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 2 Jun 2023. Initiation: voluntary: firm initiated. Monarch PCM, LLC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Monarch PCM, LLC, Fort Worth, TX.
Reason for recall
"Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content"
Distribution
"TN only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 15,730 bottles | Class III | Terminated | 25 May 2022 |
Context
Other enforcement events for Monarch PCM, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Sep 2021 | Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, | Drug | Class II | 1 |
| 2 Sep 2021 | Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PE | Food | Class II | 1 |
| 1 Sep 2021 | Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl | Drug | Class III | 2 |
All 4 events for Monarch PCM, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "TN only"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Jun 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.