TG United, Inc.

Brooksville, FL, United States

44

Total Recalls

0

Class I Recalls

0

Ongoing Recalls

Recalls by TG United, Inc.

FDA Drug Class II Terminated

TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10

January 30, 2013 TG United, Inc. 386 - 1000-count bottles units
FDA Drug Class II Terminated

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

January 30, 2013 TG United, Inc. 355 - 16 ounce bottles units
FDA Drug Class II Terminated

CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30

January 30, 2013 TG United, Inc. 26,315 - 30 mL bottles. units
FDA Drug Class II Terminated

Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30

January 30, 2013 TG United, Inc. 216,838 bottles - 30 mL units
FDA Drug Class II Terminated

Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

January 30, 2013 TG United, Inc. 330158 Bulk tablets. units
FDA Drug Class II Terminated

Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16

January 30, 2013 TG United, Inc. 12,120 - 16 ounce bottles units
FDA Drug Class II Terminated

BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16

January 30, 2013 TG United, Inc. 22,721 - 16 ounce bottles units
FDA Drug Class II Terminated

BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

January 30, 2013 TG United, Inc. 16,836 bottles - 100-count. units
FDA Drug Class II Terminated

AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles. units
FDA Drug Class II Terminated

Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30

January 30, 2013 TG United, Inc. 12,988 - 30 mL bottles. units
FDA Drug Class II Terminated

AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04

January 30, 2013 TG United, Inc. 1398 - 4 ounce bottles units
FDA Drug Class II Terminated

AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

January 30, 2013 TG United, Inc. 242,470 units
FDA Drug Class II Terminated

Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60

January 30, 2013 TG United, Inc. 977,719 Bulk Tablets units
FDA Drug Class II Terminated

ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

January 30, 2013 TG United, Inc. 39,801 - 30 mL bottles. units
FDA Drug Class II Terminated

Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01

January 30, 2013 TG United, Inc. 1623 bottles of 100-count tablets. units
FDA Drug Class II Terminated

ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16

January 30, 2013 TG United, Inc. 4811 - 16 ounce bottles. units
FDA Drug Class II Terminated

AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30

January 30, 2013 TG United, Inc. 6551 30 mL bottles units
FDA Drug Class II Terminated

Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16

January 30, 2013 TG United, Inc. 2388 - 16 ounce bottles. units
FDA Drug Class II Terminated

AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01

January 30, 2013 TG United, Inc. 1772 bottles per 100 count each units
FDA Drug Class II Terminated

Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30

January 30, 2013 TG United, Inc. 39,403 - 30 mL bottles units
FDA Drug Class II Terminated

TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

January 30, 2013 TG United, Inc. 13,031 30 mL bottles. units
FDA Drug Class II Terminated

AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60

January 30, 2013 TG United, Inc. 978,092 Bulk Tablets units
FDA Drug Class II Terminated

BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01

January 30, 2013 TG United, Inc. 10,036 bottles - 100-count tablets units
FDA Drug Class II Terminated

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

January 30, 2013 TG United, Inc. 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce. units
FDA Drug Class II Terminated

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

January 30, 2013 TG United, Inc. 2706 bottles of 100 count tablets units
FDA Drug Class II Terminated

AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10

January 30, 2013 TG United, Inc. 2957 bottles 100-count tablets units
FDA Drug Class II Terminated

Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

January 30, 2013 TG United, Inc. 40,149 - 30 mL bottles. units
FDA Drug Class II Terminated

AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles. units
FDA Drug Class II Terminated

Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01

January 30, 2013 TG United, Inc. 31,739 bottles 100-count; 842,617 Bulk tablet bottles units
FDA Drug Class II Terminated

AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

January 30, 2013 TG United, Inc. 886 bottles - 100-count tablets units
FDA Drug Class II Terminated

AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16

January 30, 2013 TG United, Inc. 352 - 16 ounce bottles units
FDA Drug Class II Terminated

TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

January 30, 2013 TG United, Inc. 2532 - 16 ounce bottles. units
FDA Drug Class II Terminated

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

January 30, 2013 TG United, Inc. 8296 bottles - 100-count and 153,028 Bulk tablets units
FDA Drug Class II Terminated

Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

January 30, 2013 TG United, Inc. N/A units
FDA Drug Class II Terminated

Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16

January 30, 2013 TG United, Inc. 4,884 - 16 ounce bottles units
FDA Drug Class II Terminated

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

January 30, 2013 TG United, Inc. 57,936 bottles - 20 mL and 7,476 bottles -16 ounce units
FDA Drug Class II Terminated

NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01

January 30, 2013 TG United, Inc. 4824 bottles - 100-count units
FDA Drug Class II Terminated

Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

January 30, 2013 TG United, Inc. 12,198 - 16 ounce bottles. units
FDA Drug Class II Terminated

TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16

January 30, 2013 TG United, Inc. 98,202 16 ounce bottles. units
FDA Drug Class II Terminated

Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30

January 30, 2013 TG United, Inc. 26,536 bottles - 30 mL units