Drug recall: AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured…
Class II FDA enforcement event 64188. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II, in the words of FDA
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
TG United, Inc. started this drug recall on 30 Jan 2013. The firm address in the FDA record is in Brooksville, FL. FDA put the recall in Class II. FDA event 64188 has 44 product records. The first FDA enforcement report date is 12 Jun 2013. The record gives the status Terminated, with the termination date 30 Sep 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
FL, MS, SC, LA and TX
Recalling firm
TG United, Inc., Brooksville, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
44 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-503-2013 | 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 | 1398 - 4 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-504-2013 | AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16 | 348 - 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
| D-505-2013 | 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 | 352 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-506-2013 | 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 | 348 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-507-2013 | 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 | 348 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-508-2013 | AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16. | 348 - 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
| D-509-2013 | 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. | 355 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-510-2013 | 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. | 348 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-511-2013 | 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 | 348 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-512-2013 | AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01 | 1772 bottles per 100 count each | Class II | Terminated | 12 Jun 2013 |
| D-513-2013 | AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01 | 886 bottles - 100-count tablets | Class II | Terminated | 12 Jun 2013 |
| D-514-2013 | 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 | 2957 bottles 100-count tablets | Class II | Terminated | 12 Jun 2013 |
| D-515-2013 | ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01 | 242,470 | Class II | Terminated | 12 Jun 2013 |
| D-516-2013 | NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01 | 4824 bottles - 100-count | Class II | Terminated | 12 Jun 2013 |
| D-517-2013 | Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01 | 31,739 bottles 100-count; 842,617 Bulk tablet bottles | Class II | Terminated | 12 Jun 2013 |
| D-518-2013 | Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01 | 8296 bottles - 100-count and 153,028 Bulk tablets | Class II | Terminated | 12 Jun 2013 |
| D-519-2013 | BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16 | 22,721 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-520-2013 | Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30 | 26,536 bottles - 30 mL | Class II | Terminated | 12 Jun 2013 |
| D-521-2013 | Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30 | 216,838 bottles - 30 mL | Class II | Terminated | 12 Jun 2013 |
| D-522-2013 | Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01 | 2706 bottles of 100 count tablets | Class II | Terminated | 12 Jun 2013 |
| D-523-2013 | Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01 | 1623 bottles of 100-count tablets. | Class II | Terminated | 12 Jun 2013 |
| D-524-2013 | BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01 | 10,036 bottles - 100-count tablets | Class II | Terminated | 12 Jun 2013 |
| D-525-2013 | BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01 | 16,836 bottles - 100-count. | Class II | Terminated | 12 Jun 2013 |
| D-526-2013 | 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 | 57,936 bottles - 20 mL and 7,476 bottles -16 ounce | Class II | Terminated | 12 Jun 2013 |
| D-527-2013 | 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 | 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce. | Class II | Terminated | 12 Jun 2013 |
| D-528-2013 | Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16 | N/A | Class II | Terminated | 12 Jun 2013 |
| D-529-2013 | Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01 | 330158 Bulk tablets. | Class II | Terminated | 12 Jun 2013 |
| D-530-2013 | Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60 | 977,719 Bulk Tablets | Class II | Terminated | 12 Jun 2013 |
| D-531-2013 | 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 | 978,092 Bulk Tablets | Class II | Terminated | 12 Jun 2013 |
| D-532-2013 | TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10 | 386 - 1000-count bottles | Class II | Terminated | 12 Jun 2013 |
| D-533-2013 | CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30 | 6551 30 mL bottles | Class II | Terminated | 12 Jun 2013 |
| D-534-2013 | CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30 | 26,315 - 30 mL bottles. | Class II | Terminated | 12 Jun 2013 |
| D-535-2013 | Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16 | 12,120 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-536-2013 | Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16 | 4,884 - 16 ounce bottles | Class II | Terminated | 12 Jun 2013 |
| D-537-2013 | TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16 | 2532 - 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
| D-538-2013 | TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16 | 98,202 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
| D-539-2013 | TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30 | 13,031 30 mL bottles. | Class II | Terminated | 12 Jun 2013 |
| D-540-2013 | Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16 | 12,198 - 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
| D-541-2013 | Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30 | 39,403 - 30 mL bottles | Class II | Terminated | 12 Jun 2013 |
| D-542-2013 | Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30 | 40,149 - 30 mL bottles. | Class II | Terminated | 12 Jun 2013 |
| D-543-2013 | Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30 | 12,988 - 30 mL bottles. | Class II | Terminated | 12 Jun 2013 |
| D-544-2013 | Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16 | 2388 - 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
| D-545-2013 | ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30 | 39,801 - 30 mL bottles. | Class II | Terminated | 12 Jun 2013 |
| D-546-2013 | ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16 | 4811 - 16 ounce bottles. | Class II | Terminated | 12 Jun 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 44
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-503-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 64188. https://recallregister.com/fda/ii/64188/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
FL, MS, SC, LA and TX
- What quantity of product is in FDA event 64188?
- The event has 44 product records. The first record gives this quantity:
1398 - 4 ounce bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.