Multi-event January 2013 FDA Recall Drug by Tg United, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Tg United, Inc. on January 30, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL, MS, SC, LA and TX and the recall is currently terminated.

Reported Recall Events

D-534-2013 TERMINATED D-535-2013 TERMINATED D-503-2013 TERMINATED D-516-2013 TERMINATED D-520-2013 TERMINATED D-531-2013 TERMINATED D-517-2013 TERMINATED D-536-2013 TERMINATED D-509-2013 TERMINATED D-543-2013 TERMINATED D-507-2013 TERMINATED D-539-2013 TERMINATED D-537-2013 TERMINATED D-508-2013 TERMINATED D-545-2013 TERMINATED D-523-2013 TERMINATED D-546-2013 TERMINATED D-514-2013 TERMINATED D-525-2013 TERMINATED D-505-2013 TERMINATED D-532-2013 TERMINATED D-530-2013 TERMINATED D-527-2013 TERMINATED D-540-2013 TERMINATED D-512-2013 TERMINATED D-529-2013 TERMINATED D-506-2013 TERMINATED D-541-2013 TERMINATED D-513-2013 TERMINATED D-521-2013 TERMINATED D-515-2013 TERMINATED D-510-2013 TERMINATED D-522-2013 TERMINATED D-511-2013 TERMINATED D-518-2013 TERMINATED D-528-2013 TERMINATED D-519-2013 TERMINATED D-533-2013 TERMINATED D-524-2013 TERMINATED D-544-2013 TERMINATED D-542-2013 TERMINATED D-504-2013 TERMINATED D-526-2013 TERMINATED D-538-2013 TERMINATED

Recall Number: D-534-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
26,315 - 30 mL bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-535-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
12,120 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16

Batch or Lot Expiration Information

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.

Recall Number: D-503-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
1398 - 4 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 12HQ002 Exp. 07/14.

Recall Number: D-516-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
4824 bottles - 100-count

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01

Batch or Lot Expiration Information

Lot# 11K010 Exp. 09/13.

Recall Number: D-520-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
26,536 bottles - 30 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30

Batch or Lot Expiration Information

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

Recall Number: D-531-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
978,092 Bulk Tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-517-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
31,739 bottles 100-count; 842,617 Bulk tablet bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01

Batch or Lot Expiration Information

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.

Recall Number: D-536-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
4,884 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16

Batch or Lot Expiration Information

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

Recall Number: D-509-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
355 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12DQ004, Exp. 03/14.

Recall Number: D-543-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
12,988 - 30 mL bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 11DQ004 Exp 03/13.

Recall Number: D-507-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
348 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 12HQ006, Exp. 07/14.

Recall Number: D-539-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
13,031 30 mL bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

Batch or Lot Expiration Information

Lot# 12GQ003 Exp 06/14.

Recall Number: D-537-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
2532 - 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

Batch or Lot Expiration Information

Lot# 11AQ003 Exp 12/12.

Recall Number: D-508-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
348 - 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12HQ007 Exp. 07/14.

Recall Number: D-545-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
39,801 - 30 mL bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

Batch or Lot Expiration Information

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

Recall Number: D-523-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
1623 bottles of 100-count tablets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01

Batch or Lot Expiration Information

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

Recall Number: D-546-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
4811 - 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16

Batch or Lot Expiration Information

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

Recall Number: D-514-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
2957 bottles 100-count tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 11E002 Exp. 04/2013.

Recall Number: D-525-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
16,836 bottles - 100-count.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

Batch or Lot Expiration Information

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.

Recall Number: D-505-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
352 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 12DQ005, Exp. 03/14.

Recall Number: D-532-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
386 - 1000-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10

Batch or Lot Expiration Information

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.

Recall Number: D-530-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
977,719 Bulk Tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-527-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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.

Recall Number: D-540-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
12,198 - 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

Batch or Lot Expiration Information

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.

Recall Number: D-512-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
1772 bottles per 100 count each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-529-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
330158 Bulk tablets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

Batch or Lot Expiration Information

Lot# 12L005 Exp 10/14.

Recall Number: D-506-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
348 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 12HQ005, Exp. 07/14.

Recall Number: D-541-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
39,403 - 30 mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30

Batch or Lot Expiration Information

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

Recall Number: D-513-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
886 bottles - 100-count tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

Batch or Lot Expiration Information

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

Recall Number: D-521-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
216,838 bottles - 30 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30

Batch or Lot Expiration Information

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.

Recall Number: D-515-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
242,470

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

Batch or Lot Expiration Information

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.

Recall Number: D-510-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
348 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12HQ003, Exp. 07/14.

Recall Number: D-522-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
2706 bottles of 100 count tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

Batch or Lot Expiration Information

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.

Recall Number: D-511-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
348 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 12HQ004, Exp. 07/14.

Recall Number: D-518-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
8296 bottles - 100-count and 153,028 Bulk tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

Batch or Lot Expiration Information

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.

Recall Number: D-528-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

Batch or Lot Expiration Information

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.

Recall Number: D-519-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
22,721 - 16 ounce bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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.

Recall Number: D-533-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
6551 30 mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30

Batch or Lot Expiration Information

Lot# 11GQ003 Exp 06/13.

Recall Number: D-524-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
10,036 bottles - 100-count tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01

Batch or Lot Expiration Information

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

Recall Number: D-544-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
2388 - 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16

Batch or Lot Expiration Information

Lot# 11EQ004 Exp 04/13.

Recall Number: D-542-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
40,149 - 30 mL bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

Batch or Lot Expiration Information

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

Recall Number: D-504-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
348 - 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 12DQ002, Exp. 03/14.

Recall Number: D-526-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
57,936 bottles - 20 mL and 7,476 bottles -16 ounce

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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.

Recall Number: D-538-2013

Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Initiated
01-30-2013
Reported
06-12-2013
Quantity
98,202 16 ounce bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64188
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TG United, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MS, SC, LA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2016
Product Description About Product Description
Full technical description of the product.
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16

Batch or Lot Expiration Information

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