D-527-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 12, 2013
- Initiation Date
- January 30, 2013
- Termination Date
- September 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Product Description
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, 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# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013.