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.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIHCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIHCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIHCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIGentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIEstradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIEstradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIEstradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIDiazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IICyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IICyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IICataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIAcetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIAcetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- 2013-07-10FDA-DrugClinical Specialties Compounding PharmacyClass IIAcetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- 2013-07-10FDA-DrugPfizer Inc.Class IIIPrempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
- 2013-07-10FDA-DrugPfizer Inc.Class IIIPrempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
- 2013-07-10FDA-DrugBaxter Healthcare Corp.Class IIMetronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- 2013-07-10FDA-DrugBaxter Healthcare Corp.Class IISodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- 2013-07-10FDA-DrugBaxter Healthcare Corp.Class IILidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- 2013-07-10FDA-DrugBaxter Healthcare Corp.Class IIHeparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- 2013-07-10FDA-DrugBaxter Healthcare Corp.Class II5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- 2013-07-10FDA-DrugBaxter Healthcare Corp.Class II0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- 2013-07-03FDA-DrugBaxter Healthcare Corp.Class II0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
- 2013-07-03FDA-DrugIndelicare LLCClass IIINK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
- 2013-07-03FDA-DrugIndelicare LLCClass IIINK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
- 2013-07-03FDA-DrugKareway Product IncClass IIPure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
- 2013-07-03FDA-DrugHospira Inc.Class II0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
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