D-526-2013 Class II Terminated
FDA drug recall D-526-2013 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: 57,936 bottles - 20 mL and 7,476 bottles -16 ounce.
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
- 57,936 bottles - 20 mL and 7,476 bottles -16 ounce
Product Description
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
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# 11CQ005 Exp. 02/13; Lot# 11LQ002 Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003 Exp. 04/14; Lot# 12EQ004 Exp. 04/14; Lot# 12JQ004 Exp. 08/14.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-526-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026