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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

TG United, Inc.: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Agency Publication Date: June 4, 2013
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Affected Products

Product: 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

Lot # 12HQ002 Exp. 07/14.

Lot Numbers:
12HQ002
Product: AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16

Lot # 12DQ002, Exp. 03/14.

Lot Numbers:
12DQ002
Product: 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

Lot # 12DQ005, Exp. 03/14.

Lot Numbers:
12DQ005
Product: 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

Lot # 12HQ005, Exp. 07/14.

Lot Numbers:
12HQ005
Product: 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 66870-0224-16

Lot # 12HQ006, Exp. 07/14.

Lot Numbers:
12HQ006
Product: AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.

Lot # 12HQ007 Exp. 07/14.

Lot Numbers:
12HQ007
Product: 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.

Lot # 12DQ004, Exp. 03/14.

Lot Numbers:
12DQ004
Product: 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 66870-0230-16.

Lot # 12HQ003, Exp. 07/14.

Lot Numbers:
12HQ003
Product: 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 66870-0229-16

Lot # 12HQ004, Exp. 07/14.

Lot Numbers:
12HQ004
Product: AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01

Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.

Lot Numbers:
11D001
11D002
11K003
12C010
Product: AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

Lot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.

Lot Numbers:
12C007
12C008
Product: 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

Lot # 11E002 Exp. 04/2013.

Lot Numbers:
11E002
Product: ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

Lot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.

Lot Numbers:
11L008
12A001
12A002
12A006
12A006
12A007
12D013
12F002
12H006
12J001
12J001
12K005
12M002
12M003
Product: NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01

Lot# 11K010 Exp. 09/13.

Lot Numbers:
11K010
Product: Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01

Lot# 11L006 Exp. 10/13; Lot# 11L006 Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005 Exp. 03/14; Lot# 12D005 Exp. 03/14; Lot# 12H001 Exp. 07/14.

Lot Numbers:
11L006
11L006
12B003
12B003
12D005
12D005
12H001
Product: Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/2014; Lot# 12F013 Exp. 05/2014.

Lot Numbers:
12B001
12B001
12B002
12F013
12F013
Product: BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16

Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14.

Lot Numbers:
12B001
12B001
12B002
12F013
12F013
Product: Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30

Lot# 11DQ009 Exp. 03/13; Lot# 11JQ002 Exp. 08/13.

Lot Numbers:
11DQ009
11JQ002
Product: Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30

Lot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13.

Lot Numbers:
11CQ001
11CQ009
11JQ003
11JQ004
11MQ002
Product: Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

Lot# 11B002 Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007 Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14.

Lot Numbers:
11B002
11B003
11G007
11J002
11K002
12C011
Product: Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01

Lot# 11G006 Exp. 06/13; Lot# 11K001 Exp. 09/13; Lot # 11K001 Exp. 09/13; Lot# 12C009 Exp. 02/14.

Lot Numbers:
11G006
11K001
11K001
12C009
Product: BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01

Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.

Lot Numbers:
11A001
11L002
12K007
Product: BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

Lot# 11A002 Exp. 12/12; Lot# 11A003 Exp. 12/12; Lot # 11A004 Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13.

Lot Numbers:
11A002
11A003
11A004
11A005
11L003
Product: 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

Lot# 11CQ005 Exp. 02/13; Lot# 11LQ002 Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003 Exp. 04/14; Lot# 12EQ004 Exp. 04/14; Lot# 12JQ004 Exp. 08/14.

Lot Numbers:
11CQ005
11LQ002
12CQ005-Exp
12EQ003
12EQ004
12JQ004
Product: 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# 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.

Lot Numbers:
11AQ004
11AQ005
11AQ006
11AQ007
11BQ012
11LQ003
11LQ004
11LQ005
11LQ006
Product: Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005 Exp. 12/12; Lot # 11AQ006 Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 - 19728 20 mL, Exp. 01/13; Lot# 11LQ003 Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/13.

Lot Numbers:
11AQ004
11AQ005
11AQ006
11AQ007
11BQ012
11LQ003
11LQ004
11LQ005
11LQ006
Product: Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

Lot# 12L005 Exp 10/14.

Lot Numbers:
12L005
Product: Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60

Lot# 11F005 Exp 05/13; Lot# 11M008 Exp 11/13; Lot# 12J003 Exp 08/12.

Lot Numbers:
11F005
11M008
12J003
Product: 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

Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.

Lot Numbers:
11F003
11M007
12J002
Product: TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10

Lot# 11A006 Exp 12/12; Lot# 11A007 Exp 12/12; Lot# 11G004 Exp 06/14; Lot# 11G005 Exp 06/14; Lot# 12C004 Exp 02/14; Lot# 12F007 Exp 05/14; Lot# 12F008 Exp.05/14; Lot #12F009 Exp. 05/14; Lot# 12G005 Exp 06/14.

Lot Numbers:
11A006
11A007
11G004
11G005
12C004
12F007
12F008
12F009
12G005
Product: CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30

Lot# 11GQ003 Exp 06/13.

Lot Numbers:
11GQ003
Product: CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30

Lot# 11EQ007 Exp 04/13; Lot# 12BQ001 Exp. 01/14..

Lot Numbers:
11EQ007
12BQ001
Product: Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16

Lot# 11CQ010 Exp 02/13; Lot# 11EQ003 Exp. 04/13; Lot# 11FQ002 Exp. 05/13; Lot# 11FQ003 Exp. 05/13; Lot# 12HQ009 Exp. 07/14.

Lot Numbers:
11CQ010
11EQ003
11FQ002
11FQ003
12HQ009
Product: Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16

Lot# 11DQ001 Exp 03/13; Lot# 11MQ010 Exp. 11/13.

Lot Numbers:
11DQ001
11MQ010
Product: TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

Lot# 11AQ003 Exp 12/12.

Lot Numbers:
11AQ003
Product: TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16

Lot# 11CQ011 Exp 02/13; Lot# 11DQ007 Exp. 03/13; Lot# 11DQ008 Exp. 03/13; Lot# 11EQ002 Exp. 04/13; Lot # 11KQ004 Exp 09/13; Lot# 11KQ005 Exp. 09/13

Lot Numbers:
11CQ011
11DQ007
11DQ008
11EQ002
11KQ004
11KQ005
Product: TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

Lot# 12GQ003 Exp 06/14.

Lot Numbers:
12GQ003
Product: Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

Lot# 11FQ004 Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002 Exp. 09/13; Lot#11KQ003 Exp. 09/13; Lot# 12HQ010 Exp. 07/14.

Lot Numbers:
11FQ004
11KQ001
11KQ002
11KQ003
12HQ010
Product: Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30

Lot# 11EQ010 Exp 04/13; Lot# 12AQ001 Exp. 12/13; Lot# 12JQ006 Exp. 08/14.

Lot Numbers:
11EQ010
12AQ001
12JQ006
Product: Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

Lot# 11EQ008 Exp 04/13; Lot# 11HQ003 Exp. 07/13; Lot# 12JQ007 Exp. 08/14.

Lot Numbers:
11EQ008
11HQ003
12JQ007
Product: Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30

Lot# 11DQ004 Exp 03/13.

Lot Numbers:
11DQ004
Product: Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16

Lot# 11EQ004 Exp 04/13.

Lot Numbers:
11EQ004
Product: ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

Lot# 11EQ009 Exp 04/13; Lot# 12AQ004 Exp. 12/13; Lot# 12KQ001 Exp. 09/14.

Lot Numbers:
11EQ009
12AQ004
12KQ001
Product: ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16

Lot# 11CQ012 Exp 02/13; Lot# 12GQ002 Exp. 06/14.

Lot Numbers:
11CQ012
12GQ002

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 64188
Status: Resolved
Manufacturer: TG United, Inc.
Manufactured In: United States
Units Affected: 43 products (1398 - 4 ounce bottles; 348 - 16 ounce bottles.; 352 - 16 ounce bottles; 348 - 16 ounce bottles; 348 - 16 ounce bottles; 348 - 16 ounce bottles.; 355 - 16 ounce bottles; 348 - 16 ounce bottles; 348 - 16 ounce bottles; 1772 bottles per 100 count each; 886 bottles - 100-count tablets; 2957 bottles 100-count tablets; 242,470; 4824 bottles - 100-count; 31,739 bottles 100-count; 842,617 Bulk tablet bottles; 8296 bottles - 100-count and 153,028 Bulk tablets; 22,721 - 16 ounce bottles; 26,536 bottles - 30 mL; 216,838 bottles - 30 mL; 2706 bottles of 100 count tablets; 1623 bottles of 100-count tablets.; 10,036 bottles - 100-count tablets; 16,836 bottles - 100-count.; 57,936 bottles - 20 mL and 7,476 bottles -16 ounce; 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.; 330158 Bulk tablets.; 977,719 Bulk Tablets; 978,092 Bulk Tablets; 386 - 1000-count bottles; 6551 30 mL bottles; 26,315 - 30 mL bottles.; 12,120 - 16 ounce bottles; 4,884 - 16 ounce bottles; 2532 - 16 ounce bottles.; 98,202 16 ounce bottles.; 13,031 30 mL bottles.; 12,198 - 16 ounce bottles.; 39,403 - 30 mL bottles; 40,149 - 30 mL bottles.; 12,988 - 30 mL bottles.; 2388 - 16 ounce bottles.; 39,801 - 30 mL bottles.; 4811 - 16 ounce bottles.)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.