Fort Worth, TX, United States
Monarch PCM, LLC recalls
4 recalls recorded since 2018, most recently on 14 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 14 April 2022
- Terminated
- 2 June 2023
- Reason
- Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
- Distribution
- TN only
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Drugs
- Recall started
- 23 September 2021
- Terminated
- 23 June 2023
- Reason
- Finished product specification did not meet USP specifications.
- Distribution
- TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0855-2021
- Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01
Terminated Class II Food
- Recall started
- 2 September 2021
- Terminated
- 22 November 2023
- Reason
- Stability is out of spec at 81% for 3 month time period.
- Distribution
- UT
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-1020-2021
- Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
Terminated Class III Drugs
- Recall started
- 1 September 2021
- Terminated
- 21 June 2023
- Reason
- Subpotency: one product for active ingredient assay and another one for preservative assay
- Distribution
- OH, TN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0818-2021, D-0817-2021
- Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5
- 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 oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-R
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.