D-524-2013 Class II Terminated
FDA drug recall D-524-2013 was initiated by TG United, Inc. on Jan 30, 2013 and is designated Class II. Reason for recall: CGMP Deviations: Products are underdosed or have an incorrect dosage regime. The recall status is terminated (terminated Sep 30, 2016). Affected quantity: 10,036 bottles - 100-count tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2013
- Initiation Date
- Jan 30, 2013
- Termination Date
- Sep 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,036 bottles - 100-count tablets
Product Description
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Distribution Pattern
FL, MS, SC, LA and TX
Code Information
Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-524-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026