Home / Recalls / Monarch PCM, LLC / D-0878-2022

D-0878-2022 Class III Terminated

Recalled by Monarch PCM, LLC — Fort Worth, TX

Recall Details

Product Type
Drugs
Report Date
May 25, 2022
Initiation Date
April 14, 2022
Termination Date
June 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

Other recalls by Monarch PCM, LLC

  • D-0855-2021 Class II — Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufa (September 23, 2021)
  • F-1020-2021 Class II — Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elem (September 2, 2021)
  • D-0818-2021 Class III — Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx o (September 1, 2021)
  • D-0817-2021 Class III — Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42 (September 1, 2021)