Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2013-06-12FDA-DrugTG United, Inc.Class IIBroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIBroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIMaxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIMaxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IICardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IICardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIBROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIDallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIDallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IINoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIRyddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIAMBI 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugHospira Inc.Class IIDOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
- 2013-06-12FDA-DrugHospira Inc.Class IIDiazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
- 2013-06-05FDA-DrugMylan Pharmaceuticals Inc.Class IIRopinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
- 2013-06-05FDA-DrugPhysicians Total Care, Inc.Class IIICamila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- 2013-06-05FDA-DrugAurobindo Pharma USA IncClass IIILisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
- 2013-06-05FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIICamrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
- 2013-06-05FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIISeasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
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