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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64188
Product Type Drugs
Status Ongoing
Recalling Firm TG United, Inc.
City Brooksville
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern FL, MS, SC, LA and TX

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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.. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 26,315 - 30 mL bottles. D-534-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 6551 30 mL bottles D-533-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 386 - 1000-count bottles D-532-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 978,092 Bulk Tablets D-531-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 977,719 Bulk Tablets D-530-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 330158 Bulk tablets. D-529-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. D-528-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce. D-527-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 57,936 bottles - 20 mL and 7,476 bottles -16 ounce D-526-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 16,836 bottles - 100-count. D-525-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 1623 bottles of 100-count tablets. D-523-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 10,036 bottles - 100-count tablets D-524-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 4811 - 16 ounce bottles. D-546-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 39,801 - 30 mL bottles. D-545-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 2388 - 16 ounce bottles. D-544-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 12,988 - 30 mL bottles. D-543-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 40,149 - 30 mL bottles. D-542-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 39,403 - 30 mL bottles D-541-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 12,198 - 16 ounce bottles. D-540-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 13,031 30 mL bottles. D-539-2013
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 Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 98,202 16 ounce bottles. D-538-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 2532 - 16 ounce bottles. D-537-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 355 - 16 ounce bottles D-509-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 2706 bottles of 100 count tablets D-522-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 216,838 bottles - 30 mL D-521-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 26,536 bottles - 30 mL D-520-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 22,721 - 16 ounce bottles D-519-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 8296 bottles - 100-count and 153,028 Bulk tablets D-518-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 31,739 bottles 100-count; 842,617 Bulk tablet bottles D-517-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 4824 bottles - 100-count D-516-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 242,470 D-515-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 2957 bottles 100-count tablets D-514-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 886 bottles - 100-count tablets D-513-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 1772 bottles per 100 count each D-512-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 348 - 16 ounce bottles D-511-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 348 - 16 ounce bottles D-510-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 348 - 16 ounce bottles. D-508-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 348 - 16 ounce bottles D-507-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 348 - 16 ounce bottles D-506-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 352 - 16 ounce bottles D-505-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 348 - 16 ounce bottles. D-504-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 1398 - 4 ounce bottles D-503-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 4,884 - 16 ounce bottles D-536-2013
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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. 12,120 - 16 ounce bottles D-535-2013
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