Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
FL, MS, SC, LA and TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-527-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 30, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TG United, Inc.
Original FDA data
Every field from FDA enforcement report D-527-2013, exactly as published.
Show all FDA fields
- City
- Brooksville
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64188
- Address
- 16275 Aviation Loop Dr
- 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.
- Postal code
- 34604-6805
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-527-2013
- Classification
- Class II
- Recalling firm
- TG United, Inc.
- Product quantity
- 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
- Termination date
- Sep 30, 2016
- Reason for recall
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- FL, MS, SC, LA and TX
- Recall initiation date
- Jan 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2013