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-DrugTHE COMPOUNDING SHOP, INC.Class IIDexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIDexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIBetamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIBaclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIBaclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIBaclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIAvastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-06-12FDA-DrugTHE COMPOUNDING SHOP, INC.Class IIMethotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-06-12FDA-DrugPhysicians Total Care, Inc.Class IIMetronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
- 2013-06-12FDA-DrugTG United, Inc.Class IIZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIZ-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIZ-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITrigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITrigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIMesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIMesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IICPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IICPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IITG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIPoly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIPoly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIPoly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IILusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIBroveX 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- 2013-06-12FDA-DrugTG United, Inc.Class IIBroveX 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
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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