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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 17221–17240 of 17,860 recalls

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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.

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

January 30, 2013 · DrugView details →

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