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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 17241–17260 of 17,860 recalls

Class IITerminated

BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.

Mylan Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.

January 30, 2013 · DrugView details →

Class IITerminated

Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

Class IITerminated

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

TG United, Inc.

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

January 30, 2013 · DrugView details →

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