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
Reported: June 12, 2013 Initiated: January 30, 2013 #D-526-2013
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.
Details
- Recalling Firm
- TG United, Inc.
- Units Affected
- 57,936 bottles - 20 mL and 7,476 bottles -16 ounce
- Distribution
- FL, MS, SC, LA and TX
- Location
- Brooksville, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by TG United, Inc.. Units affected: 57,936 bottles - 20 mL and 7,476 bottles -16 ounce.
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-526-2013.
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