BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
Reported: June 12, 2013 Initiated: January 30, 2013 #D-524-2013
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.
Details
- Recalling Firm
- TG United, Inc.
- Units Affected
- 10,036 bottles - 100-count tablets
- Distribution
- FL, MS, SC, LA and TX
- Location
- Brooksville, FL
Frequently Asked Questions
What product was recalled? ▼
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01. Recalled by TG United, Inc.. Units affected: 10,036 bottles - 100-count tablets.
Why was this product recalled? ▼
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-524-2013.
Related Recalls
CPSC Moderate
Huaker Magnetic Balls and Rods Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violates the Small Ba…
Shenzhen Huakechuang Technology Co. Ltd., dba Huaker, of China · 2026-02-19
CPSC Moderate
JJGoo LED Balloon Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Sta…
Shenzhen Yimu Technology Co., Ltd. dba JJGoo, of China · 2026-02-19
CPSC Moderate
Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labe…
Joly's LLC, of Orlando, Florida · 2026-02-19
CPSC Moderate
Prismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Sta…
Prismatic 3D Prints LLC of Loveland, Colorado · 2026-02-19
CPSC Moderate
SAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory …
Shenzhenshilonghuaqujialebeibaihuoshanghang (Jialebei Department Store, Longhua District, Shenzhen) dba Samit Outdoor, of China · 2026-02-19